FAQ

Frequently Asked Questions

Calibration

Can I exclude the contributor due to the Device Under Test (DUT) from the uncertainty claim made on the calibration certificate issued to my client?

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No. Contributions to the uncertainty stated on the calibration certificate shall include contributions that can reasonably be attributed to the customer’s device. The exclusion option only applies for the uncertainty calculation that supports the calibration and measurement capabilities (CMCs) on the Scope of Accreditation.

What does Calibration and Measurement Capability (CMC) mean?

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The following is taken from ILAC-P14:11/2010 “ILAC Policy for Uncertainty in Calibration”:

In the context of the CIPM MRA and ILAC Arrangement, and in compliance with the CIPM-ILAC Common Statement, the following definition is agreed upon:

A CMC is a calibration and measurement capability available to customers under normal conditions:

As described in the laboratory’s scope of accreditation granted by a signatory to the ILAC Arrangement; or

As published in the BIPM key comparison database (KCDB) of the CIPM MRA.

Can I issue an accredited calibration certificate that lists an uncertainty that is smaller than the Calibration and Measurement Capability (CMC) listed on my scope of accreditation?

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The definition of Calibration and Measurement Capability (CMC) implies that, within its accreditation, a laboratory is not entitled to claim a smaller uncertainty of measurement than the CMC. This means that the laboratory shall be required to state a larger uncertainty than that corresponding to the CMC whenever it is established that the actual calibration process adds significantly to the uncertainty of measurement. Typically, the equipment under calibration may give a contribution. The actual uncertainty of measurement can never be smaller than the CMC.

Can I quote my Calibration and Measurement Capability (CMC) as the uncertainty for any calibration I perform?

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In general, no. CMCs are usually calculated based on optimistic (but realistic) estimates of the uncertainty contributors. Unless the conditions of an actual calibration match the assumptions used to estimate the CMC, the calibration uncertainty will generally be larger than the CMC.

The uncertainty of reported measurements has to be stated as the actual uncertainty of the measurement, not as the accredited CMC unless that CMC actually applies. An indiscriminate use of the CMC as the uncertainty of an actual calibration is not justified.

On the other hand, some calibration labs will calculate CMCs based on the worst conditions that they’re likely to see. In these cases, the CMC on the scope of accreditation will be large enough to cover all of those conditions. This is why some labs quote their accredited CMCs for most of their work. Although this method is acceptable, it has the disadvantage that it doesn’t allow the lab to quote a smaller uncertainty if a calibration is performed under conditions better than were assumed for the scope of accreditation.

Does the Calibration and Measurement Capability (CMC) have to include a contributor due to the Device Under Test (DUT)?

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The following is taken from R218 – Applications for Calibration Scopes of Accreditation as adapted from ILAC-P14:11/2010 ILAC Policy for Uncertainty in Calibration:

The term “best existing device” is defined as a device to be calibrated that is commercially or otherwise available for customers, even if it has a special performance (stability) or has a long history of calibration.

In the formulation of CMC, laboratories shall include a contributor due to the performance of the “best existing device” which is available for a specific category of calibrations, however, it is recognized that for some calibrations a “best existing device” does not exist or contributions to the uncertainty attributed to the device significantly affect the uncertainty. If such contributions to uncertainty from the device can be separated from other contributions, then the contributions from the device may be excluded from the CMC statement under the following conditions:

Documentation of the contribution to the CMC from the device shall be included as part of the record of CMC calculation.

Documentation of the justification for the exclusion of the contribution of the “best existing device” from the CMC shall be included as part of the record of CMC calculation.

The scope of accreditation shall contain a footnote that clearly identifies that the contributions to the uncertainty from the device are not included.

Example 1: “The contributions from the ‘best existing device’ are not included in the CMC claim.”

Example 2: “The CMC for this Parameter/Equipment applies for performance verification of the ‘best existing’ device under test and not for the assignment of reference values, and therefore certain characteristics of the ‘best existing’ device under test (e.g., resolution) are not included in this CMC estimate.”

Why are some Calibration and Measurement Capabilities (CMCs) given as functions of length or resolution or some other parameter?

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The CMC is normally stated numerically, but where the CMC is a function of the quantity to which it refers (or any other parameter), it should be given in the form of an equation. For example, the dominant uncertainty contributor for calipers is often resolution. In these cases, the best way to represent uncertainty is as a function of the resolution (e.g., U = 0.6R) where "R" is the resolution in microinches. Similarly, gage blocks often quantify uncertainty based on length (e.g., U = 4 + 3L) where “L” is the length of the block in inches.

General

What is a CAB?

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A Conformity Assessment Body (CAB) is defined in the general requirements for accreditation bodies (ISO/IEC 17011) as a “body that performs conformity assessment services and that can be the object of accreditation.” This is meant to encompass the variety of organizations that A2LA accredits (i.e., laboratories, inspection bodies, product certification bodies, reference material producers, proficiency testing providers) and provides for a shared vernacular when discussing accreditation topics.

How does A2LA determine the number of assessors that will be assigned to perform our assessment?

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The most important factor in determining the number of assessors that will be assigned is the size and breadth of the proposed Scope of Accreditation.

For example, a Conformity Assessment Body (CAB) that is seeking accreditation for only one field of testing, one calibration discipline, or a single area of inspection, usually one assessor will suffice.

If the CAB is seeking accreditation in multiple fields of testing, multiple calibration disciplines, or multiple conformity assessment standards, multiple technical experts may be needed to cover all the tests, types of tests, calibrations, inspections, etc. that are being proposed for the Scope(s).

Other factors that are taken into consideration include the size of the facility and the level of measurements being made (especially in calibration).

Each decision is handled on a case-by-case basis after careful review of the application and the desired Scope(s) of Accreditation.

You can discuss the number of assessors being assigned in more detail with your assigned Accreditation Officer (AcO).

Does A2LA have recognition from specific organizations in the United States?

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Yes. Domestic recognition of A2LA programs include formal written agreements between A2LA and users of accredited organizations, officially documented endorsements of A2LA programs, and informal acceptance between A2LA and various parties. A2LA is formally recognized by a number of respected organizations. The domestic listing includes Federal, State, and local agencies, and private sector parties with whom A2LA has formal written agreements of recognition or documented endorsement.

What impact have heightened world tensions had on A2LA's international activities?

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A2LA Management has published a comprehensive A2LA Foreign Travel Policy that discusses A2LA's position on this matter. This document may be found by searching for P117 - A2LA Foreign Travel Policy on the A2LA website.

In summary, staff and assessors are strongly discouraged from traveling to to any economy where there is a Travel Warning recommending that non-essential travel be avoided because of a high risk of threats against Americans and United States interests, or because of heightened health risks.

Staff and assessors are permitted to travel under a Travel Alert, and it is suggested that they register in the Smart Traveler Enrollment Program (STEP) on the State Department website (http://travel.state.gov/content/passports/english/go/step.html) prior to departing on any trip that is affected by a Travel Alert.

The information listed on the State Department website identifies whether the travel advisory applies to all of the economy or only to some parts of it. Travel can be undertaken to those areas where an adverse travel advisory does not apply.

Staff and assessors may elect not to travel to an area under a Travel Alert. A2LA does, however, need to balance client requirements against staff and assessor travel concerns. Other members of staff or assessors who are willing and able to travel to these areas may undertake the activity after consultation with A2LA Management.

A2LA Management will advise its customers of its travel policy if activities are in economies with travel warnings and alerts. These customers will also be informed that these advisories may change from time to time and that A2LA will notify them of any changes that have an impact on the ability of A2LA staff or assessors to travel to that economy.

Please contact us with any questions related to this policy and the impact on A2LA international activities.

How is "Laboratory Accreditation" different from "Quality Systems Registration and Certification"?

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Terms such as "quality system registration" or "audit to the intent of" convey a process of verifying that the organization in question is following a documented quality management system in accordance with the quality system elements of standards (e.g. ISO 9000). These processes do not normally assess technical competence. Auditors used for such processes may have general experience in the type of business being audited, but are normally not technical experts. Technical competence is not evaluated during these processes.

How long does it take to obtain A2LA accreditation?

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The key factor in determining the time it will take to obtain A2LA accreditation is the applicant’s readiness. Applicants that have taken the time to prepare for on-site assessments, and that respond quickly to assessment deficiencies, can complete the process in a timely manner.

At this time, A2LA has all necessary resources, including staff and assessor resources, to accredit a well-prepared applicant in three to six months. Some applicants will complete this process faster, while others may never complete the process.

Key factors that can delay the accreditation process include:

Incomplete application packages

Measurement uncertainty budget issues

Delays in responding to deficiencies

What are the requirements for A2LA Accreditation?

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The requirements for which a CAB is normally assessed includes:

Internationally-recognized conformity standard (e.g. ISO/IEC 17025);

A2LA policies including:

Making reference to A2LA accredited status;

Measurement traceability;

Proficiency testing;

General requirements;

Specific requirements in certain fields (where applicable).

3. Technical requirements of the tests, calibrations, inspections, product certifications, etc. for which the CAB is seeking accreditation;

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A2LA has developed a short document entitled I105 – Typical Steps in Preparing for the Accreditation Process for Testing and Calibration, which may be found in the Resource Center.

How much does A2LA Accreditation cost?

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The cost to obtain accreditation will vary depending on the size of the organization seeking accreditation, the size of the Scope(s) of Accreditation, and the organization's readiness for assessment. Upon request, A2LA will provide a formwritten e-requeststimate of costs associated with accrediting your organization. Get An Estimate.

The assessors used to conduct the conformity assessments must be technical experts in their fields. The assessors must verify the CAB’s capabilities, which are then listed on a "scope of accreditation." CABs must also participate in proficiency testing (when applicable) on a regular basis to demonstrate their competency.

What is the "scope of accreditation"?

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The list of specific tests, types of tests, calibrations, product certifications, etc. for which a Conformity Assessment Body (CAB) is found competent is listed in a scope of accreditation. The final content of the scope must be approved by the assessors and the selected members of the A2LA Accreditation Council. Scopes don't always include all of the CAB’s capabilities. This is either because the CAB requests to limit the scope, or because the assessors have not been able to affirm the CAB’s competency in all areas for which the CAB was seeking accreditation. Capabilities that are not listed on the scope are not covered by the CAB’s A2LA accreditation.

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The introduction to ISO/IEC 17025 notes that accreditation bodies can use the standard as a basis for their accreditation. As A2LA is an accrediting body that is a signatory to the ILAC mutual recognition arrangement, some additional requirements, such as metrological traceability, proficiency testing, and use of the accredited symbol, are enacted by all AB signatories to the arrangement. In certain fields, additional specific technical requirements are developed to complement the ISO/IEC 17025 requirements.

When should we enroll in proficiency testing programs?

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Laboratories that intend to apply in the near future should enroll in available proficiency testing (PT) programs as soon as possible. In most cases, A2LA requires at least one PT activity prior to accreditation to demonstrate competency. It can take several weeks before a PT program can include you on the sample distribution list, and this could delay your final accreditation.

What are the proficiency testing requirements for laboratories seeking accreditation?

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A2LA now publishes all proficiency testing (PT) requirements applicable to all fields of testing/calibration in one document, the A2LA General Requirements for Proficiency Testing for Accredited Testing and Calibration Laboratories.

What are A2LA's Metrological Traceability Policies?

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A2LA's general Metrological Traceability Policy requires that all measuring and test equipment that must be calibrated be conducted by all of the following:

Recognized accredited calibration laboratories

Recognized National Metrology Institute (NMI)

A State Weights and Measures facility with a current certificate of measurement traceability

Recognized accredited calibration laboratories are those whose accreditation bodies are part of the international mutual recognition arrangements (MRAs) for IAAC, ILAC, and APLAC; and from NMI's recognized through the CIPM MRA. The purpose of an international MRA is to ensure a comprehensive on-site peer evaluation of an accreditation body against the requirements ISO/IEC 17011.

The main goal of these MRAs is the acceptance of test data across national and international trade barriers. All signatories must have established their credibility in their countries and have confidence in the competency and credibility of the other signatory accreditation bodies. In order to do this, all signatories must participate—hence the peer evaluation and approval process.

Recognition signifies mutual confidence that the laboratories accredited by the signatories have been equivalently assessed and are competent in the fields for which accreditation has been granted. Signatories to the MRAs continuously harmonize the assessment and accreditation processes used by the accreditation bodies to ensure acceptance internationally.

Non-accredited calibrations performed by accredited or non-accredited laboratories do not meet the A2LA Traceability Policy. To qualify as an accredited calibration , the capability must be included on the accredited laboratory's scope of accreditation issued by the accreditation body and an endorsed report is received.

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There are five accreditation bodies (ABs) in the United States that are signatories to one or more Mutual Recognition Arrangements (MRAs) for the accreditation of calibration laboratories. In addition to A2LA, other acceptable ABs may be found at www.ILAC.org.Calibration laboratories accredited by these organizations can therefore be used to meet the A2LA Traceability Policy. Use of a U.S. calibration laboratory accredited by one of our international MRA partners is also acceptable. Finally, you can use a national metrology institute (NMI) such as NIST in the United States.

How are exceptions to the A2LA Traceability Policy handled?

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Exceptions to the A2LA Traceability Policy can be made for Measuring and Test Equipment (M&TE) for which an acceptable accredited source of calibration is not currently available or when an acceptable accredited source of calibration is currently available but special circumstances regarding the nature of the calibration precludes the laboratory from obtaining an accredited calibration. These exceptions are evaluated on a case-by-case basis and require that the organization seeking an exception maintain documentation to support traceability of the calibration results received from the unaccredited provider.

An acceptable accredited source includes recognized National Metrology Institutes, such as NIST, and calibration laboratories accredited by A2LA or one of our mutual recognition partners.

What happens during the assessment if our calibration services are not accredited by an accreditation body recognized by A2LA?

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In general, A2LA's assessors will cite laboratories with a deficiency in cases when calibration services fail to use an accredited lab or a national metrology institute (such as NIST). However, exceptions can be granted if there is no accredited calibration provider available or if there is some other extraordinary circumstance. In order to receive an exception, the laboratory must have the appropriate documentation to support traceability of the calibration results provided by the unaccredited calibration provider. This documentation will be reviewed by the assessor during the onsite assessment and may also require review by A2LA staff.

Lodging a Complaint

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In order for us to investigate and assist in resolving your concerns, we ask that you submit as much information as possible about the problem/incident about which you are complaining. Whenever possible, please describe in writing the exact nature of your concern and include names of individuals involved and dates of events. Attach copies of any relevant documentation to support your claims.

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If the issue relates to a dispute with an A2LA-accredited organization, we recommend that, as a first step, you register your complaint directly with the organization in question. In accordance with ISO management system requirements, all accredited organizations must have a complaint-handling procedure which they must follow in addressing your complaint. If your concerns are not satisfactorily resolved by communicating directly with the organization in question, we encourage you to contact A2LA by any of the mechanisms described above.

Who evaluates A2LA?

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Evaluation of A2LA is done through the peer evaluation process. A peer evaluation is the internationally accepted mechanism used to formally evaluate and recognize accreditation bodies.

To obtain recognition internationally, A2LA has demonstrated competency and credibility though the peer evaluation process.

During our peer evaluations, representatives from peer accreditation bodies (fellow signatories to an international MLA or MRA) have visited A2LA for a week or more at a time, and have reviewed the following aspects of A2LA:

A comprehensive report, including non-conformities and concerns, is always prepared.

The accreditation body under evaluation must then resolve the non-conformities, and in some cases, must be re-evaluated. Once a resolution is complete, the report is submitted to an approval panel made up of other peer accreditation body representatives for voting to determine if the accreditation body will be invited to sign a mutual recognition arrangement. All signatories must be re-evaluated on a periodic basis.

The process is rigorous, and rightfully so. It is imperative that the signatories to an MRA or MLA have mutual confidence in the accreditation being granted by other signatories since signatories are obligated to promote the accreditation of the other accreditation bodies as equivalent to their own.

The goal of accreditation is to facilitate the acceptance of data in both domestic and international markets. In order to ensure that A2LA accreditation offers the greatest value possible, A2LA has endeavored to establish the widest recognition, both domestically in its own economy, and with cooperating accreditation bodies throughout the world.

Documents

How do I access documents for the field in which I am accredited?

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You can access all the documents related to your laboratory’s the field of accreditation in your customer portal under “Relevant Documents.”

How do I access documents when I am not a current customer?

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To access our most widely used documents you can find them in the Resource Center. For the remaining documents, contact us to request the documents you are interested in receiving. Please note that some checklists contain copyrighted material excerpted from a published standard and will be sent once we have received confirmation that the laboratory owns a copy of the corresponding standard.

How do I know when documents have changed?

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Subscribe to email notifications to stay informed about the latest updates to the A2LA documents. Current customers may also access the updated documents through the CAB Portal or new Customer Portal. In addition, document change notifications are published in 2LA Today, our quarterly newsletter, and is freely available on our website.

How do I know what has changed within a document?

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There are two ways to determine what changed within an A2LA document. First, review the document history for a summary of the most recent changes, furthermore, if you sign up for document change notifications, these will also contain information on the content of the changes made.

Filing a Complaint

How do I file a complaint with A2LA?

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Speak directly to the Quality Manager, Pamela Wright, by calling 301-644-3248. A2LA requests that serious verbal complaints be followed up in writing in order for us to ensure that details of your complaint are captured accurately.

What information do I need to provide A2LA when I file a complaint?

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In order for A2LA to investigate and assist in resolving your concerns, please submit as much information as possible about the problem or incident, including the following:

Provide supporting copies of any relevant documentation to support your claims.

What is the process for managing disputes with A2LA-accredited organizations?

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If the issue relates to a dispute with an A2LA-accredited organization, we recommend that, as a first step, you register your complaint directly with the organization in question. In accordance with ISO management system requirements, all accredited organizations must have a complaint-handling procedure.

If your concerns are not satisfactorily resolved by communicating directly with the organization in question, we encourage you to contact A2LA.

Veterinary

What types of organizations are accredited under A2LA’s Veterinary Program?

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The goal of A2LA’s Animal Health Program is to promote animal health through the accreditation of veterinary and animal drug testing laboratories. A2LA-accredited veterinary laboratories include government, academic, and commercial organizations responsible for a variety of activities including disease surveillance and disease diagnostics for commercially- and privately-owned animals.

What standards are used to accredit laboratories under A2LA’s Veterinary Program and who recognizes this accreditation?

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Veterinary laboratories are accredited to ISO/IEC 17025 and OIE Quality Standard and Guidelines for Veterinary Laboratories: Infectious Diseases, 2008. The ISO standard is non-prescriptive and is flexible to the needs of the laboratory. This accreditation is accepted by the National Animal Health Laboratory Network (NAHLN) as one way to meet their evaluation criteria. Additionally, ISO/IEC 17025 accreditation is an internationally-recognized statement of competency and can be valuable when applying for government funding, importing or exporting animal products, or for use as a marketing tool.

What areas of my laboratory will the assessor review?

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An A2LA laboratory assessment includes a thorough examination of the laboratory’s compliance with the requirements of ISO/IEC 17025 and the OIE Standard as well as its compliance with its own internal policies and procedures. Additionally, for each applicant to the A2LA accreditation program, a Scope of Accreditation is drafted. This document is a list of all of the tests for which the laboratory is seeking accreditation. A2LA assessors perform an assessment of the methods listed on the Scope to ensure that the laboratory is technically competent to perform them. It is important to note that this technical assessment is limited to activities directly related to the tests on the proposed Scope of Accreditation, allowing applicants to manage the areas they wish to have assessed. Organizations may apply for as many or as few tests as they wish.

What does A2LA Accreditation cost?

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The cost to obtain accreditation will vary depending on the size of the laboratory seeking accreditation, the number of tests on the proposed Scope of Accreditation, and the laboratory's readiness for assessment. Estimates are available at no cost for interested parties and discounts are available for multi-location organizations.

What resources are available to aid in the accreditation process?

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A2LA assigns a dedicated Accreditation Officer to every single applicant. This person is a point of contact for the laboratory for the lifetime of their accreditation, providing assistance and support throughout the accreditation process. For specific questions or a free estimate, please contact Program Manager Lauren Smith (LSmith@A2LA.org and (240) 575 7482) or Accreditation Officer Anna Williams (AWilliams@A2LA.org and (240) 575 7494).

Additionally, to assist laboratories in preparing for accreditation, A2LA offers commercially available training courses on the preparation and implementation of a quality management system and specific aspects of the standard such as root cause analysis and corrective action. Please visit the A2LA Training Page at https://www.a2la.org/training for a list of upcoming courses.

How is A2LA governed as an Accreditation Body?

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A2LA is a signatory to the ILAC Mutual Recognition Arrangement (MRA). This means that A2LA has been found to be compliant with ISO/IEC 17011, the standard by which accrediting bodies are to operate, and has been found to accredit laboratories to ISO/IEC 17025 in a manner consistent with other MRA signatory accreditation bodies around the world.

A2LA is regularly evaluated by a panel of its MRA signatory peers to ensure continued compliance. Due to A2LA’s ILAC recognition, accredited laboratories find that A2LA maintains a process that ensures the ISO/IEC 17025 standard is applied fairly to all organizations without bias or inconsistent interpretations

Forensic

Why did A2LA launch a forensic program?

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A2LA is in business to serve its customers and to fulfill its vision of “being the premier provider of accreditation accepted everywhere and by everyone.” When our customers asked us to develop a program, it was not a question of whether we should, but how we could do it effectively and competently and become the leader in the industry.
A2LA offers accreditation programs for:

*Please see A2LA.org for a full description of each program and subprogram (accreditation landing page)

A2LA is uniquely qualified to offer customers a comprehensive accreditation through use of trained and highly skilled technical assessors and A2LA staff.

What is the difference between A2LA and other accreditors that offer forensic accreditation?

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A2LA was one of the original signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) and since that time has been very actively involved on ILAC committees, working groups and task groups to assist in the growth and promotion of the ILAC MRA and accreditation. In addition, A2LA maintains accreditation programs in multiple standards and disciplines and has options for dual accreditation and joint assessments. A2LA is also the only accreditation body in the United States that is internationally-recognized for ISO 15189 (clinical) accreditation and which has been recognized by the Centeres for Medicare & Medicaid Services (CMS) for clinical laboratory accreditation under CLIA. A2LA is also the only accreditation body in the United States that is recognized by the United States Government for their RedRAMP program for IT Cloud Computing accreditation (ISO/IEC 17020).

A2LA contracts with technical experts working in forensic fields to assist in the performance of assessments; ensuring that the most experienced and technically competent individuals are selected to act as A2LA assessors.

A2LA is a professional society run for and by its members. Membership in A2LA is open to all interested parties, not just accredited customers (e.g. specifiers, regulators, end users) and comes with many benefits, including the right to vote on officers and directors of the Association and discounts on A2LA training programs. An organization does not have to be a member to become accredited, and accreditation by itself does not confer A2LA membership.

The Forensic Examination Advisory Committee (FEAC) is open to all interested parties and meetings are held in person and through webinar and teleconference to allow options for participation by full Committee membership. The FEAC is tasked with the development of accreditation and assessment guidelines in accordance with the ISO/IEC 17025 and ISO/IEC 17020 requirements and with reviewing and reaching consensus on how relevant technical methods, procedures, protocols, techniques and/or guidelines are to be interpreted and assessed.

A2LA continues to grow its programs through research, community participation and interaction with technical experts to provide customers with comprehensive accreditation offerings. Through A2LA’s numerous programs and subprograms, A2LA is able to offer accreditation in even the most unique areas of forensic testing and inspection, such as forensic odontology and anthropology.

A2LA serves the forensic community by hosting training classes online and in-person, through attendance and presentation at meetings, and through participation on committees and commissions.

A2LA staff maintain memberships with numerous forensic associations; including the AAFS, IAI, CBD-IAI, AFQAM and ASTM forensic committees, Maryland Forensic Laboratory Advisory Committee (FLAC), forensic working group of the International Laboratory Accreditation Cooperation (ILAC), forensic working group of the Inter-American Accreditation Cooperation (IAAC), Organization for Scientific Area Committees (OSAC) Quality Infrastructure Committee and the National Commission of Forensic Sciences (NCFS) Subcommittee on Accreditation and Proficiency Testing.

A2LA contracted assessors maintain memberships with ASTM forensic committees and forensic scientific working groups (SWGs), technical working groups (TWGs), and Organization for Scientific Area Committees (OSAC) Scientific Area Committees (SACs) as well as continuing to work in their respective fields.

Since launching the program, what formal recognitions has A2LA received?

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As of September 2014, the A2LA forensic accreditation program has been evaluated and recognized by the states of Maryland and Texas. In addition, the National DNA Index System (NDIS) Procedures Board has reviewed and formally approved the designation of A2LA as an accrediting agency under the United States Federal DNA Identification Act (42 U.S.C. 14132).
Through legislative mandate, the A2LA forensic accreditation program is also recognized in Alabama, California, Hawaii, Idaho, Illinois, Indiana, and Minnesota.

I don’t know a lot about the Federal DNA Identification Act, can you tell me more about your approval?

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The Federal DNA Identification Act allows for the collection and indexing of DNA Profiles and sets requirements for the maintenance of the system including the laboratories that may perform testing and the accreditation bodies that may accredit them. A2LA underwent rigorous review by the NDIS Procedures board including a review of all program materials, peer evaluation of A2LA performing an FBI QAS assessment, and evaluation of A2LA DNA assessors, and was found to meet the requirements as set forth in the Federal DNA Identification Act, thus approving A2LA to assess and accredit laboratories that would like to take part in the system.

How involved is A2LA in the forensic community?

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A2LA serves the forensic community by hosting training classes online and in-person, through attendance and presentations at meetings, and through participation on committees and commissions.

A2LA staff maintain memberships with numerous forensic associations including the AAFS, IAI, CBD-IAI, AFQAM and ASTM forensic committees, Maryland Forensic Laboratory Advisory Committee (FLAC), forensic working group of the International Laboratory Accreditation Cooperation (ILAC), forensic working group of the Inter-American Accreditation Cooperation (IAAC), Organization for Scientific Area Committees (OSAC) Quality Infrastructure Committee, and the National Commission of Forensic Sciences (NCFS) Subcommittee on Accreditation and Proficiency Testing.

A2LA contracted assessors maintain memberships with ASTM forensic committees and forensic scientific working groups (SWGs) and technical working groups (TWGs) as well as continuing to work in their respective fields.

My unit performs a number of activities, but I’m only ready to get my latent prints section accredited. Can I do this?

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As an applicant to the A2LA forensic accreditation program, you are asked to identify the activities which you would like to include within your scope of accreditation. A2LA does not place limitations or requirements on what activities at your facility must be accredited and we work with you to ensure that all requested areas that are deemed compliant are captured on your scope.

In addition, A2LA has a well-documented system for processing requests for scope expansion and reduction and will work with you to ensure a swift and stress-free process. A2LA does not charge fees for scope expansions; however, if a significant amount of data must be reviewed or if an on-site assessment is needed, you would be charged for the technical assessor’s time. In all cases, A2LA will communicate with you to ensure that you understand any potential costs prior to moving forward.

My unit collects and uploads fingerprints to the AFIS system; are we eligible for accreditation?

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A2LA recognized that all phases of the forensic process are critical and that these may not include testing or examinations. Such activities are identified in A2LA document R309 - Specific Requirements - Forensic Examination Accreditation Program-Inspection and include:

The evaluation and documentation of a scene;

The collection of evidence;

The transport and storage of evidence;

The inspection of evidence for compliance with known samples (e.g. bullet/cartridge case comparison, fingerprint comparison);

The submission of evidence to accredited testing laboratories for analysis; and

The determination of events based on inspection and testing results (e.g. scene reconstruction).

For those activities performed in support of forensic work, these may be accredited under the ISO/IEC 17025 or ISO/IEC 17020 standard, as applicable.

I’m ready to apply, but need to request funding from my command, can I get an estimate?

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A2LA is happy to provide a free estimate to interested forensic laboratories and units upon request. In addition, fixed price and not-to-exceed options are available.

It seems like the cost of accreditation goes up every year, what has A2LA done to help keep costs down.

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A2LA recognizes that over the years, budgets have not expanded to address the increased needs of the forensic community and that funds may be limited when it comes to obtaining accreditation. As such, A2LA has instituted a fee-based cost structure which allows A2LA to confirm a set price for assessment and continued accreditation over a number of years. In these cases, only travel expenses would adjust with inflation and even there, A2LA is taking steps to help keep costs down. A2LA does not add administrative fees to travel expenses; rather we invoice for the actual cost and provide receipts when requested. Additionally, A2LA has arrangements with car rental agencies and enforces a per diem for all A2LA travel to ensure the best possible price for our customers.

I am very active in the forensic community and know a number of other experts, what if I’m friends with the assessor that’s proposed for my assessment?

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Before assigning any assessor, A2LA will submit an assessment proposal to the applicant with short bio-sketches of each assessor outlining their background and experience. If any of the assessors present a conflict-of-interest for the applicant, they can identify the conflict to A2LA and request that an alternate assessor be proposed.

I need to have my assessment in the next two months, how quickly can you mobilize assessors?

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If you have a need to be assessed within a set time frame, A2LA will make every effort to ensure that the assessment occurs within that time frame.

The benefit of using contracted assessors is that they keep days available on their personal schedules to perform assessments throughout the year and at times, at short notice. Just recently A2LA was able to mobilize a team of assessors to perform an assessment one week after receiving a complete application.

Once I have my assessment, how quickly can I expect to be accredited?

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Following your on-site assessment, the process can move quite quickly, but this is very dependent on how quickly you can address any non-conformities that were identified during the assessment. If non-conformities were not identified, accreditation can be completed in a matter of days.

If non-conformities are identified, the time needed will depend on how quickly your organization moves through the corrective action process and how quickly you are able to provide evidence to A2LA of the resolution of any non-conformities cited. However, A2LA will ensure that you receive prompt responses to questions and that your corrective actions receive thorough and expeditious review, typically within one week. Once all non-conformances have been addressed and reviewed by an official review board, A2LA can complete your accreditation paperwork in a matter of days.

Does A2LA have a proficiency test review board?

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When a review of proficiency testing is needed, A2LA forms a review committee consisting of technical experts in the forensic discipline or sub-discipline in which the proficiency test was offered as well as experts in proficiency testing and statistical techniques, where needed.

A2LA selects review committee members from the A2LA assessor corps and members of the A2LA Forensic Examination Advisory Board (FEAC). All members of the review committee sign a confidentiality agreement to ensure the confidentiality of A2LA customers. While A2LA encourages the use of accredited proficiency test providers, it is recognized that use of accredited providers is not required and that there exists a number of providers of varied quality available to the forensic community. Additionally, a number of factors may cause a proficiency test to produce outlying results and due to this, A2LA does not interpret outlying results to be a ‘fail.’ Rather, outlying results are viewed as an indication of a potential issue within an organization’s management system that required additional investigation and response.
To ensure a fair and reasonable review of all proficiency testing, A2LA first asks our accredited organizations to review proficiency testing results and to submit results to A2LA within 30 days.
If an outlier is identified, the organization is asked to provide A2LA with a response and to enroll in the next round of testing for that proficiency test. The accredited organization can provide a corrective action response, contest the applicability of the proficiency test, or contest the accuracy of the proficiency test. Responses received are stripped of any identification of the organization to ensure confidentiality and are then forwarded to a selection of A2LA contracted assessors and members of the A2LA Forensic Examination Advisory Board (FEAC) for review and comment. This committee of reviewers will evaluate the proficiency test in question and the organization’s response for appropriateness of the proficiency test and reasonableness of the organization’s corrective action and/or response.

In all cases, the accredited organization must enroll in the next available round of testing for that test and provide those results to A2LA within 30 days. If the organization receives outlying results in a subsequent round, that organization’s scope of accreditation may be limited until evidence of successful performance is provided.

How does A2LA maintain the confidentiality of my documents and status within the accreditation process?

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All A2LA staff, assessors, and technical experts involved in the assessment and accreditation process must sign a conflict of interest and confidentiality policy to ensure that the confidentiality of our customers is maintained.

All information in relation to a customer’s application is kept in strictest confidence and may only be released under written approval by the customer. In cases where review by a broader audience is required, documents are stripped of any identification of the organization or excerpts are taken to ensure confidentiality.

I am already accredited by another accreditor. Can I transfer this accreditation to A2LA?

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A2LA does allow for the transfer of accreditation, provided that the requesting organization is accredited by an accreditation body that is a full member signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). In many cases, the transfer can be processed quickly and requires only a review of records and documentation. However, every situation is different and so we encourage you to contact us directly (info@A2LA.org or 301 644 3248) and we will be happy to walk you through the transfer process.

ISO/IEC 17025 Forensic Accreditation

What is ISO/IEC 17025 and what is its basis?

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ISO/IEC 17025 General Requirements for the competence of testing and calibration laboratories is a standard that provides the specific requirements for quality and competence that are particular to testing and calibration laboratories. The standard promotes global harmonization of testing and calibration. ISO/IEC 17025 is used by laboratory customers, regulatory authorities and accreditation bodies to ensure competence.

What is a “quality management system”?

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A quality management system (QMS), as required by ISO/IEC 17025, is a compilation of organizational documents that establishes the policies and procedures needed to direct and control an organization with regard to quality. It relates to general management activities, the provision and management of resources, the pre-procedure, test/calibration and post-procedure processes and evaluation and continual improvement. A QMS captures the requirements of an organization and structur­ally provides a roadmap that explains who, what, when, where and how sustainable and repeatable outcomes will be achieved.

What makes up a quality management system?

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A management system consists of policies, procedures, SOPs and records, all of which provide proof of goals, assign respon­sibility, describe how those responsibilities are to be performed and provide evidence of past accounts or occurrences of compliance.

How widespread is ISO/IEC 17025? Is this accreditation program widely accepted?

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ISO/IEC 17025 is an internationally-recognized standard, with over 80 International Laboratory Accreditation Cooperation (ILAC)-recognized accreditation bodies offering ISO/IEC 17025 accreditation programs. Although ISO/IEC 17025 is not mandatory in the U.S., an increasing number of forensic organizations have recognized the benefit of being accredited by an internationally-recognized accredita­tion body (such as A2LA).

How is ISO/IEC 17025 accreditation different from ISO 9001 certification?

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ISO 9001 is a registration of a quality management system and serves as the basis for many of the other ISO standards because of its intentional generalness.
ISO/IEC 17025 incorporates the essential elements of ISO 9001 and adds technical competency underpinnings relevant to testing and calibration laboratories. Its primary application is to improve the management and techni­cal structure of testing and calibration laboratories. ISO/IEC 17025 accreditation (as opposed to ISO 9001 registration) includes both an assessment of the Management System and an evaluation of the technical competency of the testing and/or calibration laboratories.

I’m not familiar with ISO/IEC 17025; can A2LA help me to better understand the requirements of ISO/IEC 17025 and how to implement them in my laboratory?

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A2LA is a 501(c)(3) non-profit educational institution. As such we offer a variety of public training courses with the purpose of helping organizations prepare for, achieve and maintain accredita­tion to ISO standards. One course currently offered by A2LA is “ISO/IEC 17025 and Laboratory Accreditation for Forensic Organizations”, which assists attendees in understanding the ISO/IEC 17025 standard and implementing an effective quality management system.

In addition, A2LA offers both public and on-site training courses on specific principles contained within all of the ISO standards used by A2LA as the basis for our accreditation programs. Such principles include “root cause”, “corrective action”, “measurement uncertainty”, “internal audits” and “proficiency testing”.

Not all sections of my lab are ready for accreditation; can I get one section accredited and add the rest later?

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Yes. A2LA does not require that your full laboratory obtain accreditation. In addition, if you only require accreditation for a single test or small selection of tests, A2LA will assess and accredit you for only those tests.

What if I get accredited and my chemistry section wants to add an additional test that they just finished validating?

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You can add testing to your scope during your on-site assessment or between assessments by completing and submitting a request for scope expansion form (A2LA document F108 – Request for Expansion of Scope of Accreditation – Testing).

Are there any hidden fees for expanding my scope, going inactive, or relocating?

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A2LA does not charge fees for such activities. However, if review by a technical assessor or an on-site assessment is needed to confirm the continued compliance of your facility, you would be invoiced for the assessor’s time and travel expenses. In such cases, A2LA would notify you in advance of any potential cost to you before moving forward.

I perform a unique type of testing and have validated my own internal procedures. Can I list these on my scope?

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Internal procedures may be listed on A2LA Scopes of Accreditation provided they meet the requirements of ISO/IEC 17025 and the laboratory has shown through demonstration and a review of documentation and records, that they are able to perform work in accordance with that internal procedure.

ISO/IEC 17020

What is ISO/IEC 17020 and what is its basis?

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ISO/IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection is a standard that provides the specific requirements for quality and competence that are particular to inspection bodies. In the context of forensic sciences, forensic inspection is defined as the examination of an item or location and, on the basis of professional judgment, the determination of conformity with proposed events or known conditions. Of particular importance is the concept of professional judgment based on education, experience, and training and how this judgment is used in determining which collection methods and processes to use at crime scenes, when developing latent prints, and when making critical decisions in relation to identifying evidence.

What is a “management system”?

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A management system, as required by ISO/IEC 17020, is a compilation of organizational documents that establishes the policies and procedures needed to direct and control an organization with regard to quality. It relates to general management activities, the provision and management of resources, the pre-inspection, inspection and post-inspection processes and evaluation and continual improvement. A management system captures the requirements of an organization and structur­ally provides a roadmap that explains who, what, when, where and how sustainable and repeatable outcomes will be achieved.

What makes up a management system?

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A management system consists of policies, procedures, SOPs and records, all of which provide proof of goals, assign respon­sibility, describe how those responsibilities are to be performed and provide evidence of past accounts or occurrences of compliance.

While documentation of a management system is required, ISO/IEC 17020 does not require that such documentation be captured in a quality manual. This approach allows for organizations working under multiple standards (e.g. ISO 9001, ISO/IEC 17025, ISO/IEC 17020, ISO 15189) to more seamlessly integrate their management structures into one another.

How widespread is ISO/IEC 17020? Is this accreditation program widely accepted?

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In a June 2006 memorandum of understanding between the European Network of Forensic Institutes (ENFSI) and the European Cooperation for Accreditation (EA), the ISO/IEC 17020 standard was selected as the most appropriate for accreditation of crime scene inspection activities. While the ISO/IEC 17025 standard applies to all types of testing, it was noted that the process of inspecting, diagramming, and collecting items at a crime scene was not addressed. The evaluation of a crime scene requires a high level of professional judgment based on education, training, and experience and it was found that the ISO/IEC 17020 standard addressed these concerns. Since this time, accreditation of crime scene and related units to ISO/IEC 17020 has increased internationally and within the United States.

Disciplines identified as being the most appropriate for ISO/IEC 17020 accreditation include those where the examination process and final determination of results is made through the professional judgment of the forensic science practitioner. Such disciplines include crime scene analysis and reconstruction, latent print and fingerprint analysis, firearms and toolmarks, and digital forensics.

How is ISO/IEC 17020 accreditation different from ISO 9001 certification?

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ISO 9001 is a registration of a quality management system and serves as the basis for many of the other ISO standards because of its intentional generalness.

ISO/IEC 17020 incorporates the essential elements of ISO 9001 and adds technical competency factors relevant to inspection bodies. Its primary application is to improve the management and techni­cal structure of inspection bodies. ISO/IEC 17020 accreditation (as opposed to ISO 9001 registration) includes both an assessment of the Management System and an evaluation of the technical competency of the Inspection Body.

What sorts of requirements are contained within ISO/IEC 17020?

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Key requirements incorporated into the ISO/EIC 17020 standards are:

Documentation of the management system

Documented competency requirements and formal authorizations of staff

Documented training and oversight program for all inspectors

Continued evaluation of risks to impartiality and documented actions to eliminate risks

I’m not familiar with ISO/IEC 17020; can A2LA help me to better understand the requirements of ISO/IEC 17020 and how to implement them in my laboratory?

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A2LA is a 501(c)(3) non-profit educational institution. As such we offer a variety of public training courses with the purpose of helping organizations prepare for, achieve and maintain accredita­tion to ISO standards. One course currently offered by A2LA is “ISO/IEC 17020:2012 and Laboratory Accreditation for Forensic Organizations”, which assists attendees in understanding the ISO/IEC 17020 standard and implementing an effective management system.

In addition, A2LA offers both public and on-site training courses on specific principles contained within all of the ISO standards used by A2LA as the basis for our accreditation programs.

Training

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A2LA will send course material files electronically, or by mail per request. You may print copies for each course attendee and the instructor from these files.

Will I receive an official copy of the applicable ISO standard for an on-site course?

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Licensed copies of ISO standards are not provided for on-site courses; however, training copies will be provided.

Can the courses be customized for our site?

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Yes, we allow customizing with all our courses. We can customize to create overview training, or something more specific to your field. There can be additional charges for customizing a course. A2LA cannot offer consulting services.

When is payment due for on-site training? What are my payment options?

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Payment is due by sixty days after the on-site training has occurred. A2LA accepts wire transfers, checks, and all major credit cards.

Will we be billed for everything on the estimate?

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We will only bill you for the actual costs incurred, the estimate is simply a general idea of total expenses that could be incurred. The costs charged will never exceed the estimated costs.

When will we receive our course certificates?

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Once A2LA receives payment for your training, we will mail your certificates to your location.

What do you mean by estimated expenses?

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Estimated expenses are anything that will be incurred by our instructors for the training. This includes the cost of the training course, hotel, airfare, meals, gas, parking, mileage, car, travel time, miscellaneous, incidentals, etc.

Can we partner with another group in our area to offer On-Site Training?

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Yes, but we are only able to invoice one company. Therefore if you partner with another company and want to split the costs you will have to divide things on your end and send separate payments towards the same invoice.

What is the minimum and maximum number of participants allowed for on-site training?

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For on-site training you must have a minimum of four participants, but no more than twenty-five.

Can one instructor deliver multiple courses?

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It depends. Most of our course instructors have been trained to deliver multiple courses. Our technical courses require field specific expertise. Please contact Tim Osborne, Senior Director of Training Services at 301.644.3209 or via email at tosborne@A2LA.org or Ashley Smith, Training Coordinator at 301.644.3226 or via email at asmith@a2LA.org for further assistance.

Is there a discount for on-site training?

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No we do not offer a discount for on-site training.

Do I receive discounts as a government employee?

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Government employees receive the member rate. Please see CONTACT INFORMATION above to obtain more information for the discount code to apply when registering.

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On-Site training is available for every public course we offer as well as for additional courses. Please click on the following link: http://www.a2la.org/training/index.cfm# or contact Ashley Smith, A2LA Training Coordinator, at 301.644.3235 or via email at asmith@A2LA.org for more information regarding on-site training.

How do I register for an A2LA training course?

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You may register for a course by clicking on “Register” or “Register for Public Training Classes” on the A2LA website or by contacting Ashley Smith, A2LA Training Coordinator, at 301.644.3235 or via asmith@a2la.org.

Why are there two different prices listed for each course?

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The lower price is for A2LA members and the higher for non-members. If you are an A2LA member, please contact Ashley Smith, A2LA Training Coordinator, at 301.644.3226 or via asmith@A2LA.org for the discount code to use when registering.

Please note that membership dues are separate and distinct from accreditation fees. An organization does not have to be a member to be accredited, and accreditation by itself does not confer membership. If you are interested in A2LA membership, please click on the following link: http://www.a2la.org/membership/member.cfm

When is my payment due? What are my payment options?

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Payment is due at the time of registration. If you have questions please contact Ashley Smith, A2LA Training Coordinator, at 301.644.3235 or via email at asmith@a2la.org. A2LA accepts all major credit cards as well as checks for payment.

Are there discounts for multiple attendees from the same company?

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Each course is held at a hotel listed under “location” on the individual course page or under “venues” on the full training schedule page of the A2LA website. For those courses held at A2LA Headquarters in Frederick, MD, please contact Ashley Smith, A2LA Training Coordinator, at 301.644.3226 or asmith@A2LA.org, if you need recommendations for hotel accommodations in the area.

Do I need to make my own hotel reservation? Am I required to stay at the hotel listed in order to enroll in the training course?

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Please call the hotel directly to make your reservation. You may stay at any hotel and are not required to stay at the A2LA-contracted venue. The hotel fee is not included in the training course registration fee. For courses held at A2LA Headquarters, please contact please contact Ashley Smith, A2LA Training Coordinator, at 301.644.3226 or via asmith@A2LA.org for nearby hotel information.

Is the daily rate for the hotel/venue discounted?

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Yes. A2LA has secured a block of rooms at a discounted rate. Please mention A2LA when making your reservation and please be sure to make your reservation on or before the “cut-off” date.

Are meals included with my registration?

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A continental breakfast, lunch, and afternoon break are included. You will be responsible for dinner. A2LA takes great care when selecting individual venues to ensure restaurants/eateries are within walking distance of the hotel.

Will I need to rent a car? Is there shuttle service to/from airport to the course venue?

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With the exception of courses held at A2LA Headquarters, course venues are chosen so that rental cars are not a necessity. Restaurants, etc. are located nearby for your convenience. Many hotels offer shuttle service. Please contact the hotel directly to inquire whether or not this service is available. For courses held at A2LA Headquarters, a rental car is recommended due to the distance (approximately 45 minutes) from local airports.

Do I need to bring anything to class?

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No. All materials will be provided at the start of each course. Blank notepads, notebooks or post-it notes are not provided, however.

Is there a dress code?

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No. Most people dress in business casual attire.

Is a copy of the ISO standard included with my course registration?

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You will receive a licensed copy of the applicable ISO standard for each course with the exception of Measurement Uncertainty, Internal Auditing, and ISO/IEC 17025 for Accredited Laboratories. For these courses, you will receive “training copies” of any applicable standard to use during class.

Will I receive a certificate of attendance following the course?

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You will receive a certificate upon completion of the course, provided full payment has been received by A2LA.

Cannabis

What is the goal of A2LA’s Cannabis Testing Laboratory Program?

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The goal of A2LA’s Cannabis Testing Laboratory Accreditation Program is to promote confidence to users and regulators with regard to the safety of medical and recreational marijuana through the accreditation of cannabis testing laboratories and (when relevant) inspection bodies.

What standards are used to accredit laboratories or inspection bodies under A2LA’s Cannabis Testing Laboratory Program and who recognizes this accreditation?

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Cannabis testing laboratories are accredited to ISO/IEC 17025 and any additional requirements that may be specified by the state in which the laboratory resides or does business. The ISO 17025 standard is non-prescriptive and is sufficiently flexible to meet the needs of any laboratory. Additionally, ISO/IEC 17025 accreditation is an internationally-recognized statement of competency and can be valuable as a marketing tool. Since, in some cases, there is also a possible inspection component to the evaluation of cannabis (which may include visual or other inspection for properties such as trichrome maturity, mite damage, mold spores, odor, etc.), accreditation for these types of inspection activities would be granted within the ISO/IEC 17020 A2LA Inspection Body Accreditation Program.

What areas of my laboratory or inspection body will the assessor look at?

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An A2LA assessment includes a thorough examination of the organization’s compliance with the requirements of ISO/IEC 17025 (and the inspection body’s compliance to ISO/IEC 17020), its compliance with its own internal policies and procedures as well as compliance to any applicable state specific requirements. Additionally, for each applicant to the A2LA accreditation program, a Scope of Accreditation is drafted. This document is a list of all of the tests or inspections for which the organization is seeking accreditation. A2LA assessors perform an assessment of the methods or inspections listed on the Scope to ensure that the organization is technically competent to perform them. It is important to note that this technical assessment is limited to activities directly related to the tests and/or inspections on the proposed Scope of Accreditation, allowing applicants to manage the areas they wish to have assessed. Organizations may apply for as many or as few tests and/or inspections as they wish.

What factors should states consider when developing legislation for allowing compassionate use of [Medical] Marijuana?

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There are many approaches to consider while developing a state accreditation program for laboratories. To summarize likely options, the state could either:

1. Develop a list of criteria for laboratory performance and quality assurance, develop an inspection protocol, provide inspectors, and accredit laboratories themselves based upon these criteria; or
2. Make accreditation by the state contingent upon the laboratory being accredited by an ILAC-recognized accreditation body that has assessed the laboratory to the relevant international standard such as ISO/IEC 17025 (testing) and/or ISO/IEC 17020 (inspection); or
3. Make accreditation by the state contingent upon prior accreditation of the laboratory by an ILAC-recognized accreditation body that has assessed the laboratory to the relevant international standard such as ISO/IEC 17025 (testing) or ISO/IEC 17020 (inspection) and impose additional criteria that the state would deem necessary, such as specifying test methods, proficiency testing requirements, etc.

All of these options would be a step above what most states require for cannabis testing laboratories. Requiring ISO/IEC 17025 and/or ISO/IEC 17020 accreditation, as a component of recognition by the state, is the most stringent option and provides the state with the most assurance that the laboratory is performing acceptably. It would also provide the public with the most assurance that the state is doing all that it can to ensure the integrity of testing and/or inspection.

Clinical

What does “ISO” stand for?

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ISO is not an acronym; it is a word chosen by the International Organization for Standardization. “ISO” is taken from the Greek word “isos,” meaning equal. The three official languages of ISO are English, French and Russian; thus the organization’s name would have different acronyms in different languages. For this reason, it adopted the short name ISO (a registered trademark of the organization) which is the same in every country.

What is the International Organization for Standardization?

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The organization today known as ISO began in 1926 as the International Federation of the National Standardizing Associations (ISA) and became known as the International Organization for Standardization in 1947. The International Organization for Standardization is a worldwide federation of national standards bodies from more than 160 countries, one from each country. The national standards bodies make up the ISO membership and they represent ISO within their country.

The organization’s mission is to promote the development of standardization to facilitate the international exchange of goods and services, and to develop cooperation in the spheres of intellectual, scientific, technological, and economic activity. Its work results in international agreements, which are published as international standards.

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There are three membership categories for national standards bodies (see description below).

Full members (or member bodies) influence ISO standards development and strategy by participating and voting in ISO technical and policy meetings. Full members sell and adopt ISO International Standards nationally.

Correspondent members observe the development of ISO standards and strategy by attending ISO technical and policy meetings as observers. Correspondent members can sell and adopt ISO International Standards nationally.

Subscriber members keep up to date on ISO’s work but cannot participate in it. They do not sell or adopt ISO International Standards nationally.

The American National Standards Institute (ANSI) is the U.S. member body to ISO. ANSI coordinates the development of voluntary consensus standards in the United States and represents the needs and views of U.S. stakeholders in standardization forums around the globe. ANSI’s membership is comprised of a broad range of businesses and industrial organizations, standards setting and conformity assessment bodies, trade associations, labor unions, professional societies, consumer groups, academia and government organizations for the purpose of enhancing global business competitiveness and improving the quality of life for the world’s citizens. A2LA has been an active member on several ANSI committees for decades and, through this involvement, has been instrumental in the development of ISO standards, including ISO 15189.

What is a “standard”?

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A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. ISO International Standards ensure that products and services are safe, reliable and of good quality. They are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets and facilitate free and fair global trade.

Government and industries around the world have been using international standards for more than half a century to facilitate trade, establish a technical base for regulation and safeguard consumers.

Are ISO and ILAC synonymous or related in any way?

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ISO and ILAC are two separate entities (see below for more information about ILAC). ISO focuses on the development of standards worldwide and ILAC focuses on the deployment of those standards worldwide to promote trade and acceptance amongst member organizations. ISO and ILAC have a Memorandum of Understanding (MOU) that addresses matters of conformity assessment policy, standards development and practice as they relate to accreditation. The MOU consolidates practices and provides an ongoing mechanism for technical cooperation between ISO and international accreditors (such as A2LA) in order to contribute to the development and subsequent implementation of ISO standards.

What is ISO 15189 and what is its basis?

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ISO 15189 is a standard that provides the specific requirements for quality and competence that are particular to clinical laboratories. The standard promotes global harmonization of clinical practices. It protects the health and safety of patients and healthcare providers, supports efficient exchange of information and protection of data and improves the overall quality of care. ISO 15189 is used by laboratory customers, regulatory authorities and accreditation bodies to ensure competence.

In 2012, ISO published a revised and updated version of the standard, ISO 15189:2012 (Medical Laboratories – Requirements for Quality and Competence), which contains quality management system requirements as well as technical requirements. It also contains an increased focus on technical competence and now requires mandatory assessment against measurement uncertainty and traceability.

How widespread is ISO 15189? Is this accreditation program widely accepted?

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ISO 15189 is an internationally-recognized standard, with over 40 ILAC-recognized accreditation bodies offering ISO 15189 accreditation programs. In some countries it is the standard by which laboratories are reimbursed. Although ISO 15189 is not mandatory in the U.S., an increasing number of clinical labs have recognized the benefit of being accredited by an internationally-recognized accreditation body (such as A2LA) along with their CLIA accreditation.

How is ISO 15189 accreditation different from ISO 9001 certification?

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ISO 9001 is a registration of a quality management system and serves as the basis for many of the other ISO standards because of its intentional generalness.

What sorts of requirements are contained within ISO 15189?

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The standard is divided into five sections:

Scope

Normative references

Terms and conditions

Management requirements

Technical requirements

Sections 4 and 5 of the document make up the bulk of the standard and are the sections used to assess clinical laboratories. They contain all of the requirements for a clinical laboratory’s quality management system, as well as the technical requirements used as the basis for confirming a clinical laboratory’s competence to perform specific clinical tests.

What is ILAC?

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ILAC (the International Laboratory Accreditation Cooperation) is an international cooperation of accreditation bodies (or accreditors) formed more than 30 years ago to help remove technical barriers to trade. When first started in 1977, the aim was to develop international cooperation for facilitating trade by promoting the acceptance of accredited test and calibration results. In 1996, ILAC became a formal cooperation with a charter to establish a network of mutual recognition agreements (MRAs) among accreditors that would fulfil this aim. The ILAC Arrangement (first signed in November 2000) provides significant technical underpinning to international trade. The key to the Arrangement is the global network of accredited laboratories and inspection bodies that are assessed and recognized as being competent by ILAC Arrangement signatory accreditation bodies. The Arrangement’s accreditation body signatories have, in turn, been rigorously peer-reviewed and shown to meet ILAC’s criteria for competence.

Is an accreditor’s participation within ILAC mandatory?

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Participation within ILAC is not mandatory for all accreditors. Indeed, not every accreditor would be found to meet the stringent requirements for signatory status within the ILAC MRA and so they make the “business decision” not to seek this important recognition.

What is an ILAC “peer evaluation” and what are the benefits of undergoing one?

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A peer evaluation is the means by which an accreditation body (or accreditor) is found competent and acceptable for consideration as an ILAC MRA signatory. All ILAC MRA signatories have been rigorously evaluated by their fellow signatories to ensure their compliance with ISO/IEC 17011 (“General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies”) and to ensure that they are implementing ISO standards within the accreditation programs they offer in a manner that is consistent world-wide.

Ask yourself: “Who has accredited my accreditor?” Signatory status within an international MRA, such as ILAC, is the only answer you should accept. Otherwise, what assurance do you have that your accreditor is competently operating a program for assessment of and accreditation to ISO standards?

Why did A2LA launch a clinical program?

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A2LA launched a clinical program in an effort to continue fulfilling its vision of “being the premier provider of accreditations accepted everywhere and by everyone”.

Is A2LA an ILAC Arrangement Signatory? What is the significance of this?

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Yes, A2LA was one of the original 28 signatories to the ILAC MRA in November 2000 in Washington D.C. Our Scope of Recognition within ILAC includes the accreditation of medical testing laboratories to ISO 15189. This means that your A2LA ISO 15189 accreditation is accepted by our partners in over 70 countries around the world as being equivalent to the accreditations issued within their own countries. ISO 15189 accreditation by an organization that is not an ILAC MRA signatory can make no such statements and there is no basis for its recognition or acceptance in other countries, or even within the United States, by other accreditors.

What is the difference between A2LA and other accreditors that offer an ISO 15189 program?

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Our International Recognition:
A2LA is the largest, multi-discipline accreditor in the United States. We are a full signatory to the ILAC Mutual Recognition Arrangement (MRA), which is crucial for several different reasons:

As an ILAC MRA signatory, A2LA undergoes periodic and rigorous peer evaluations by fellow MRA signatories to ensure that it remains in compliance with ISO/IEC 17011, “General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies”. This is the ISO standard that sets out the rules and requirements for the operation of an accreditor. Without a system of peer evaluation and mutual recognition, there is no guarantee that an accreditor is operating to the highest possible standard and there is no guarantee that an accreditor is assessing and accrediting laboratories in a competent manner.

Included in A2LA’s Scope of Recognition through ILAC is the accreditation of clinical laboratories to ISO 15189. This provides an independent attestation of A2LA’s competence to offer these accreditations and A2LA is the only accreditation body in the U.S. that is internationally-recognized for ISO 15189 accreditation.

A2LA’s ILAC recognition for the accreditation of clinical testing laboratories to ISO 15189 means that your laboratory’s ISO 15189 accreditation through A2LA will be accepted internationally, breaking down restrictive barriers to trade and offering greater opportunities than accreditation through an organization that is not recognized beyond its own customer base.

Our Experience and Access to Expertise:
A2LA has gained tremendous experience in accrediting laboratories to ISO standards over the past 35 years. A2LA launched its ISO 15189 clinical accreditation program in November 2000. We have been instrumental in the revision of the standard and we currently accredit against the 2012 version. We are not new to this business and we are certainly not new to the use of ISO standards. ISO standards can be challenging to interpret and implement and so you should partner with an accreditor that knows them and has been working with them for 35 years. Our experience also spans all possible levels of expertise needed by a full service clinical laboratory, not just a single area such as pathology.

An A2LA clinical assessment is no “coffee cup audit”. Only so much can be expected of a volunteer assessor corps because they are, after all, volunteers. A2LA’s assessors, on the other hand, are paid, contracted clinical experts and they are required to undergo intensive training (including a week-long orientation course and written exam) and periodic oversight to ensure they are conducting our clinical assessments in accordance with A2LA’s procedures and strict expectations for thoroughness and professionalism. Once A2LA accreditation is achieved, you and your customers can be assured that you have demonstrated competence at the highest level, as confirmed by one of the recognized world leaders in accreditation.

A2LA has an established Medical Testing Advisory Committee (MedTAC), which is active in the development of accreditation and assessment guidelines for clinical testing laboratories in accordance with ISO 15189. The MedTAC is composed of experts in the clinical field and also affords your laboratory a chance to be heard and to be instrumental in the furtherance of the A2LA clinical laboratory accreditation program.

Our Services:
Because we are a multi-discipline accreditor, A2LA can serve as a “one stop shop” for all of an organization’s accreditation needs. We understand and accommodate the fact that many organizations do not offer just one type of testing or one type of service. A2LA can accredit for any type of testing in addition to services offered by proficiency testing providers, reference material producers, product certifiers and more. All of this can be done by one accreditor, A2LA, during one on-site visit, saving you time and money.
Do not mistake our multi-discipline nature as being a “watered down” approach to determining competence in each area for which we offer accreditation. Each of our accreditation programs is given the same attention to detail, is held to the same expectations for thoroughness and top-level expertise, and is operated with the same customer service which sets us apart from our competitors.

I have heard that A2LA and ILAC are “product–focused”, meaning that their emphasis is on and their only expertise is in the accreditation of product testing laboratories. Is this true?

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No, this is not true. The ILAC MRA includes and A2LA accredits all types of testing laboratories, not just product testing laboratories. This includes, for example, environmental testing, biological testing, forensic examination, pharmaceutical testing and clinical testing. A2LA has established accreditation programs in each of these areas, all of which are included in our Scope of Recognition under the ILAC MRA.

Does the ILAC peer evaluation of A2LA include an examination of A2LA’s ability to accredit clinical laboratories, specifically?

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Absolutely. A peer evaluation team is selected to cover all areas for which an accreditor is seeking recognition under the ILAC MRA. Therefore, each team selected to evaluate A2LA includes at least one member with internationally-recognized expertise in the clinical field. This individual then systematically examines all aspects of the A2LA clinical laboratory accreditation program, including observation of one or more actual A2LA on-site assessments of a clinical laboratory to ISO 15189.

Is A2LA as competent to accredit clinical testing laboratories as they are to accredit other types of labs?

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Absolutely. Rest assured that no accreditor is accepted into the ILAC MRA and recognized to accredit clinical labs to ISO 15189 unless they have been rigorously evaluated and found competent to do so. The fact that A2LA’s Scope of Recognition under the ILAC MRA includes accreditation of clinical laboratories to ISO 15189 provides you with an independent attestation of our competence in this area.

What aspects are there to an A2LA ISO 15189 assessment?

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An A2LA clinical laboratory assessment is a three-tiered approach. First, it includes a thorough examination of the clinical laboratory’s compliance with the requirements of ISO 15189. Second, it includes an in-depth review of the clinical laboratory’s own policies and procedures and their adherence with them. Finally, for each applicant to the A2LA clinical program, a Scope of Accreditation is drafted. This document outlines all of the specialties and sub-subspecialties (along with the specific tests performed within each) for which the clinical laboratory is seeking accreditation. A2LA assessors then perform a technical assessment against the Scope to ensure that the clinical laboratory is technically competent to perform every test listed.

How does A2LA ensure accurate evaluation of both QMS and technical issues in its ISO 15189 assessments?

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A2LA assigns assessors with the education and expertise to complement a laboratory’s desired Scope of Accreditation. All of our clinical assessors have extensive experience in assessing CLIA laboratories and have been found to meet A2LA’s stringent requirements for being contracted members of our assessor corps. A lead assessor is assigned as are additional assessors depending on the extensiveness of the laboratory’s desired Scope of Accreditation. The time spent on-site by our assessors is not only commensurate with the desired Scope and but also takes into account the time necessary for a thorough review of the laboratory’s management system. All of our assessors, while undeniably technical experts, also undergo extensive training on the assessment of all QMS elements. A2LA approaches this training as an ongoing investment to ensure the high caliber of our assessor corps. All assessors are observed and evaluated performing actual assessments and this evaluation process occurs at regular intervals throughout the term of their contract with A2LA, ensuring a continual level of consistency and expertise.

What are the steps in the A2LA accreditation process and how long does the process typically take from start to finish?

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To begin the process, the laboratory completes and returns the application for accreditation, including all supporting documentation specified within the application form. A2LA staff reviews the submitted application to ensure that it is complete and then proposes an assessor (team) based upon the laboratory’s desired Scope of Accreditation. The laboratory is informed of the proposed assessor (team) and is provided with bios to ensure that there is no actual or potential conflict of interest in having the assessor (team) visit the laboratory. Once the assessor (team) has been agreed to, the application package is provided to the assessor (team).

The (lead) assessor contacts the applicant to discuss the scheduling of the on-site assessment and, at that time, requests additional management system documentation to aid in the assessor’s document review, which is done in advance of the assessment. (Laboratory’s do have the option of undergoing a pre-assessment, during which the assessor will point out any areas that are not currently in compliance with ISO 15189 and the A2LA accreditation requirements prior to the full assessment.) A full on-site assessment is performed which includes, among other things, an entry briefing, review of management system documentation and records, examination of sample handling processes, interviews of technicians, observation of tests being performed, review of technical records and reporting processes. A written assessment report, including a report of any areas of non-conformance, is provided to the laboratory at the closing meeting of the assessment.

The laboratory then responds to any non-conformities cited by providing A2LA with a detailed corrective action response. A2LA staff reviews the corrective action response to ensure completeness and corresponds with the laboratory directly if any additional information is required. Once the laboratory’s response is complete, all information related to the assessment is forwarded to a panel of the A2LA Accreditation Council for a vote. Accreditation is granted upon receipt of affirmative votes from the Accreditation Council and once any concerns raised by the Council have been addressed.

On average, new applicants complete the accreditation process within 5 months, from start to finish. Keep in mind that this is greatly dependent upon the laboratory’s readiness, preparation and responsiveness.

Please refer to the diagram below for an overview of this process:

Can A2LA help me to better understand the requirements of ISO 15189 and how to implement them in my laboratory?

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A2LA is a 501(c)(3) non-profit educational institution. As such we offer a variety of public training courses with the purpose of helping organizations prepare for, achieve and maintain accreditation to ISO standards. One course currently offered by A2LA is “ISO 15189 and Clinical Laboratory Accreditation”, which assists attendees in understanding the benefit of the newly revised ISO 15189 standard and assists them in implementing “best in class” laboratory functions as well as pre-examination, examination and post-examination processes that address the principles of quality clinical laboratory services essential to patient care.

In addition, A2LA offers training courses on specific principles contained within all of the ISO standards used by A2LA as the basis for our accreditation programs. Principles include “root cause”, “corrective action”, “measurement uncertainty”, “internal audits” and “proficiency testing”.

Do all A2LA clinical laboratory assessments include a pathologist on the assessor team?

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Assessor teams are selected based upon a laboratory’s desired Scope of Accreditation. If a laboratory requests the specialty of pathology on their Scope, then a pathologist must be assigned as part of the assessment team. If pathology is not part of the desired Scope, then A2LA does not waste resources or your money in assigning an assessor with expertise in an area that is not relevant to your Scope of Accreditation.

How should I go about choosing an ISO 15189 accreditor?

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Similar to how you expect your customers to select a laboratory based upon their qualifications and credentials, so should you when choosing an ISO 15189 accreditor. Anyone can self-declare competence in offering ISO 15189 accreditations, but you need to ask yourself: “What are their credentials and who has accredited them?” When it comes to A2LA, the answer is easy. A2LA’s 35 years of experience in accrediting specifically to ISO standards and our signatory status within the ILAC MRA for the accreditation of clinical laboratories to ISO 15189 speak for themselves. Our technical expertise is second-to-none as is our experience with management systems and ISO standards. We not only accredit laboratories to these standards, but we are expert enough in their development and implementation to train others in how to utilize them to better their laboratory’s performance. A2LA is also the only accreditor in the United States that is recognized internationally, by virtue of our signatory status within the ILAC MRA, for the accreditation of clinical laboratories to ISO 15189.

I am already ISO 15189 accredited by another accreditor. Can I transfer this accreditation to A2LA?

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Although accreditation to ISO 15189 by an accreditor that is not a signatory to the ILAC MRA cannot be accepted as equivalent to A2LA accreditation, we strive to make the transfer process as little of a burden financially and otherwise as possible. Often, review of the on-site assessment report from another accreditor can be used as a starting-point in the A2LA assessment process, which may save you time and on-site assessor expenses. Every situation is different and so we encourage you to contact us directly (info@A2LA.org or 301 644 3248) and we will be happy to walk you through the transfer process.

Is A2LA accreditation affordable?

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A2LA is one of the most transparent organizations in the business when it comes to our fee structure. There are no hidden fees; no “document fees” or other extraneous costs. When you contact A2LA for an estimate on the cost of our accreditation, you can be confident that you are receiving a complete picture and that you will not be hit with additional fees as you progress through the program. Because the cost is determined by your desired Scope of Accreditation, we invite you to contact A2LA today (301 644 3248) to learn exactly how affordable our accreditation programs are.

For more information about A2LA, please visit our general website (www.A2LA.org) or our Clinical Laboratory Accreditation Programs pages, specifically, (www.A2LA.org/clinical) or call us directly at 301 644 3248 to discuss how A2LA can meet your needs.

Field Evaluation Bodies

What is the purpose of Field Evaluation Bodies (FEB)?

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FEBs evaluate unlabeled electrical equipment in the field to ensure it complies with the applicable codes or standards.

How do FEBs work?

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The Authority Having Jurisdiction (AHJ) makes the determination that a piece of equipment in the field has either been modified or refurbished or is not labeled appropriately. When this happens, they look to an approved FEB to evaluate the equipment, determine if the equipment complies with the applicable codes or standards, and then appropriately label the equipment.

Why do FEBs need to be accredited?

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FEBs only perform electrical equipment evaluations at the request of the AHJ. In order to receive this request, the FEB must meet the AHJ’s requirements for approval. While these requirements can vary between AHJs, accreditation is almost always an acceptable option.

What standards does an FEB need to meet?

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There are two prominent standards against which FEBs are evaluated. These are NFPA 790 – Standard for Competency of Third-Party Field Evaluation Bodies and NFPA 791 – Recommended Practice and Procedures for Unlabeled Electrical Equipment Evaluation. Many AHJs also required that FEBs be evaluated against ISO/IEC 17020 – Conformity assessment – Requirements for the operation of various types of bodies performing inspection.

What programs does A2LA offer in this area?

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A2LA offers two different options for FEBs to make the process as simple as possible. The decision of which program is best for your FEB will be based on the requirements of your AHJ and the recognitions you would like to have.

Option A includes accreditation against NFPA 790, NFPA 791, and ISO/IEC 17020. This accreditation falls under A2LA’s internationally-recognized ILAC MRA Scope of Recognition and is most appropriate for an FEB that falls under an AHJ with stricter approval requirements.

For those FEBs working under AHJs that do not require an evaluation against ISO/IEC 17020, A2LA offers an Option B, which only includes an assessment against NFPA 790 and NFPA 791. This Option results in a shorter on-site visit by A2LA and, as a result, lesser expense.

How is A2LA’s program different than the NRTL program offered by OSHA?

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The key difference between these programs is the timing and location of the certification. While FEBs and NRTLs both deal with product safety, an FEB works primarily in the field at the point of installation. An NRTL typically works at the point of manufacture instead. These are two different processes with different competency requirements.

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Careers

How do I apply for a Job at A2LA?

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Please fill out our application using the link in the job posting for employment, which will take you to an ADP-run website, and attach any supporting documents (i.e. resume, cover letter). This option is only available if there is an open position.

Do I have to create a username and password to apply?

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In order to logon to ADP, you will need to supply your email address and create a password. ADP will only send you emails related to the status of your application.

What if there are no currently open positions on your page?

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If there are any open positions at A2LA they will be listed in the Available Positions section of our career page. If there are no open positions and you would like for us to keep your resume for future consideration, please forward your resume to Lauren Bisson our HR coordinator, at lbisson@A2LA.org.

How do I know if my application has been received?

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Once you submit your information you will receive an auto-confirmation email. If you have not received a confirmation and feel that there was an error in your submission, please contact us.

How often are job openings posted?

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There is no definite number of jobs that are available at any given time. This can vary depending on the growth and development of the organization.

How long does my resume and application stay active in the system?

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We will have access to your resume for one year and your application for six months.

How long does it take to hear back from someone within your organization?

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A2LA is committed to responding to your application as quickly as possible. This can normally take one to two weeks, but can sometimes be longer depending on the position as well as the amount of applications we have received.

Will I be notified as to whether I am being considered for a position or if I was declined?

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Every person who applies for a position at A2LA, whether they meet the qualifications or not, will be responded to as soon as possible.

What is your recruitment process?

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Once you submit your application and resume, we will look over the information that you have provided to see whether or not your experience and education meet the qualifications of the job that you are applying for. If they do, a member of the HR department will reach out to you to set up a pre-screen phone interview. Based on this phone call, the appropriate staff will decide if a second, on-site interview should be conducted.

What is the salary range that A2LA offers?

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The salary range for the position you are interested in should be posted in the job description. However, your individual salary will be determined based on a combination of your education, relevant experience, and any other relevant factors.

Explanations for the ISO/IEC 17065 Requirements

My Certification Body operates under a larger corporate umbrella, and we send portions of our Evaluation work to another department in the corporation. Is this considered “outsourcing” the work to an outside body?

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Note 2 of clause 6.2.2.1 states “Use of external personnel under contract is not outsourcing.”
If there exists a properly executed agreement (e.g. contract) between the department/personnel in question and the Certification Body which meets the requirements of clause 6.1.3, then no, the example given does not constitute “Outsourcing” of activities by the Certification Body. (This documentation also answers the question, “Is the resource under the direct control of the Certification Body?” for purposes of judging whether or not the entity in question is an Internal Resource of the Certification Body – see clause 6.2.1)
If the documentation linking the other department or its personnel to the Certification Body does not meet the requirements called out under clause 6.1.3, or if the Certification Body cannot provide evidence that the additional requirements stated under clause 6.1.2 are met for the personnel in question, then the actions taken by the Certification Body are considered “Outsourcing,” and the Certification Body must demonstrate that it complies with the requirements related to Outsourced activities.

My certification body outsources our evaluation activities to an ISO/IEC 17025 accredited testing laboratory. Can we leverage the status of this laboratory’s accreditation as our means of qualifying, assessing, and monitoring this external resource?

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The NOTE below clause 6.2.2.4 clarifies when a Certification Body may utilize accreditation as part of their qualification, assessment, and monitoring of an external resource.
In summary, A2LA permits a Certification Body to reference an external resource’s accreditation (e.g. to ISO/IEC 17025) only if this is clearly allowed within the scheme(s) being operated, the resource’s scope of accreditation is applicable to the evaluation activity being performed (including appropriate test or inspection methods), and the Certification Body has a documented frequency and supporting records for verifying the accreditation status.
If the scheme does not mention allowing the Certification Body to rely on accreditation without other qualification / assessing / monitoring activities of their own, A2LA requires the Certification Body to clearly state in their required policies and procedures how the qualification / assessing / monitoring activities are undertaken, and to keep records showing that those actions have been undertaken for all approved providers of outsourced services.

My organization issues a blanket statement on our contracts which states “your product may be sent to an outside laboratory for testing in the event we are unable to perform timely evaluation” – does this meet the requirements of the standard?

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Clause 6.2.2.4(f) requires the certification body to notify the client in advance of subcontracting in order for the client to have the opportunity to object to that action. A2LA understands that certification bodies may not always immediately know what outside entity will be used to perform evaluation tasks when taking on an application.
At a minimum, the certification body may issue a blanket statement (or make known in some other clear manner) of possible subcontracting to its clients and potential clients. The client then has an opportunity to object to the use of external resources, or to request clarification on the matter. If clarification is requested, the certification body is expected to answer the client’s question, and identify the potential entity that would be used before the evaluation activity takes place in order to allow the customer the opportunity to object to the use of that particular external resource, while still accepting the possible use of a different external evaluation resource.
Records of correspondence are required to demonstrate that the CB has given adequate notice to the client and, if necessary, has identified the specific subcontractor if so requested.
The critical idea in this clause is that the CB has given the client a reasonable opportunity to object to the use of outside evaluation resources, whether that be objecting to a specific entity (such as a chosen test lab) or objecting to the entire concept of outsourcing. (Note that ISO/IEC 17065 does not explicitly require the certification body to receive a written approval from the client to initiate the subcontracting, but it may be beneficial for a certification body to attempt to obtain this documented approval.)

Is Application Review considered part of the Evaluation stage in the Certification Process, such that my Application Reviewer cannot also be a formal Reviewer (per Section 7.5) or Certification Decision Maker (per Section 7.6)?

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The Application Review stage of the certification process is a very fine line for Certification Bodies to walk when considering duties assigned to its personnel. The Application Review cannot be automatically assumed to be an Evaluation activity without further examination by an assessor. The assessor will sample certification records and will interview various persons within the Certification Process in order to collect evidence demonstrating whether or not the person taking part in the Application Review has performed activity which is considered Evaluation.
When the tasks performed by the Application Reviewer are found to be administrative in nature only (e.g. requesting missing pages from an evaluation report, requesting a missing signature on the certification agreement, or requesting a sample of the product to be certified), then no, the Application Reviewer is not considered as having performed any Evaluation tasks.
However, any work performed by the Application Reviewer which results in the selection of a product to be certified, or which results in data/information that is or could be used in determining whether or not a product meets certification requirements, is considered part of the Evaluation process. This work would then preclude the Application Reviewer from taking part in the formal certification Review (7.5) and Decision (7.6) phases of the certification process.

A client has asked us to certify a new product which we have not certified before, but this new product is somewhat similar to ones we have been certifying in the past. How do we determine whether or not we have “prior experience” with the new product we

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The Certification Body should compare the new product to be certified against those with which it has similar experience by examining the schemes (if different) used for performing the certifications, the technologies inherent in the products, the evaluation techniques which must be implemented to characterize the product to determine its compliance with the requirements in the certification scheme(s), and the technical knowledge of its own personnel in order to ensure that a knowledgeable review and decision on certification can ultimately be made.
The NOTE under this clause gives excellent guidance for the Certification Body to consider when comparing the new product they are being asked to certify against products they have certified in the past. Similar comparisons should also be made when a new certification scheme or new normative document (such as a different evaluation specification) is introduced to the Certification Body by their client.
If the certification body determines that the new product is of the same type as ones with which it has previous experience, no records are needed, but the Certification Body may be asked to explain its rationale in determining that the new product is of the same type as ones that were previously certified.
If the Certification Body cannot explain this rationale to an assessor’s satisfaction, a deficiency may be cited if the assessor can justify that a certification was not “of the same type” as certifications previously granted by the Certification Body (for example, by showing that the new product has substantial differences in technical underpinnings from those the Certification Body used in its comparison).

A2LA NOTE – Performing certifications against schemes and underlying technical standards not shown on the Certification Body’s Scope of Accreditation cannot be claimed as Accredited work in accordance with A2LA R105 - Requirements When Making Reference to A2LA Accredited Status. A2LA does offer a “F330 - Request for Expansion of Scope of Accreditation - Product Certification” form for Certification Bodies wishing to expand their Scope of Accreditation for situations such as these. The Certification Body must fill out and have the Scope expansion request approved by A2LA and their most recent assessor before offering these certifications as Accredited.

What type of records are required to justify our organization’s competence and capability to perform a certification we have not performed before (such as called out in clause 7.3.2)?

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A2LA does not specify what form a record must take that would offer justification for undertaking a new type of certification. However, the records must show that the Certification Body has performed an analysis of the new certification to be performed, and compared the requirements of the new certification against the existing experiences and competencies of its resources to perform similar certifications, as well as verifying that the certification body is capable of performing the certification activities required by the new certification being undertaken.
The justification records should be sufficiently detailed such that the assessor can reach the same conclusions that the certification body reaches with respect to moving forward with the new certification. An assessor may cite a deficiency if there is, in his or her opinion, insufficient information in the justification records for undertaking the new certifications, or supporting evidence that the certifications were improperly granted as a result of insufficient or improper justification.

A2LA NOTE – Performing certifications against schemes and underlying technical standards not shown on the Certification Body’s Scope of Accreditation cannot be claimed as Accredited work in accordance with A2LA R105 - Requirements When Making Making Reference to A2LA Accredited Status. A2LA does offer a “F330 - Request for Expansion of Scope of Accreditation - Product Certification” form for Certification Bodies wishing to expand their Scope of Accreditation for situations such as these. The Certification Body must fill out and have the Scope expansion request approved by A2LA and their most recent assessor before offering these certifications as Accredited.

Clause 7.6.4 seems to indicate that my organization MUST have organizational control over some entity. Is this the correct reading of this clause?

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A2LA reads clause 7.6.4 to be more of a definition of what Organizational Control IS, rather than something a Certification Body must exert. As such, there are many instances where Organizational Control will not come into play for a Certification Body. There are three clauses in the standard which reference Organizational Control of an outside entity by the Certification Body. A2LA assessors are instructed to examine how each Certification Body implements the following clauses, and, if no related bodies are utilized in the implementation of these steps, then clause 7.6.4 is Not Applicable for the Certification Body.
7.6.3: The Certification Body is permitted to essentially “outsource” the certification decision, but only if the person/group of persons making the decision is employed by or contracted to the Certification Body itself, or an entity that the Certification Body holds more than 50% control in. If the person/group making the decision is not employed or contracted by the CB or an “organizationally-controlled” entity, the CB cannot utilize that person or group to make the final certification decision. Note that committees are excluded from this clause by virtue of the requirements in clause 5.1.4 of the standard.
4.2.6: Any entity which the Certification Body has Organizational Control over is not permitted to design, manufacture, install, distribute, or maintain the product being certified. The Certification Body must be prepared to explain how they are ensuring that all related entities which are under Organizational Control are not performing any of these actions. Related entities NOT under Organization Control are not subject to these requirements, but are instead subject to examination for risks to impartiality under clauses 4.2.3 and 4.2.7.
7.6.5: The Certification Body must be able to demonstrate (with supporting record evidence) how it ensures that personnel in entities under organizational control are fulfilling the ISO/IEC 17065 requirements. Fulfillment of these requirements includes (but may not be limited to) requiring the existence of a contract with those personnel which meets the requirements of clause 6.1.3.

The certification scheme our organization operates does not include any guidance on the information that must be made available to the public about certified products. Is our organization allowed to make no information available in this case?

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There is a defined minimum amount of information required in clause 7.8 which must be published or made available upon request even if the scheme is silent on this subject. This minimum is “information … about the validity of a given certification,” as outlined in the final sentence of this clause (e.g. by answering “Yes, that is a valid certification”).
The certification body may certainly go above and beyond the scheme in making information publicly available, but must meet the requirements in section 4.5 of ISO/IEC 17065 (confidentiality) in those instances.

The certification scheme our organization operates uses a certification mark for ongoing certification, but is completely silent on the actual surveillance actions to be taken. How is this to be handled so that we meet the requirements of clauses 7.9.1 an

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While Note 2 under clause 7.9.1 indicates that criteria and processes for surveillance are to be defined by the certification scheme, A2LA realizes that many schemes are not written (or have not been updated) sufficiently to address the needs of the certification body.
In the case of a certification scheme being silent on any of the requirements for surveillance (e.g. frequency of surveillance, actions to be taken, percentages of certified products to be reviewed, etc.), and assuming that the Scheme Owner does not respond with any objective instruction for the certification body, A2LA requires the certification body to clarify how the surveillance will be performed, using a process similar to that called out in clause 7.1.3 for creating explanations for certification requirements. This information is then also to be made publicly available (upon request) pursuant to clause 4.6.a, as it relates to the certification scheme(s) being operated by the certification body.
The certification body must, at a minimum, define the actions taken to establish appropriate surveillance activities related to the product (e.g. how many products will be included, how they are to be acquired/selected, etc.), define the frequency of surveillance activities (e.g. per calendar year, in the first quarter of every year, etc.), and define the requirements which the product must meet (e.g. the product must meet original certification requirements in order to continue certification). The examples given in this paragraph are not meant to be all-encompassing, but should be taken as guidance in considering how to address the needs of the certification body and the ISO/IEC 17065 standard.
Additional guidance can be found in ISO/IEC 17067 for surveillance activities. A2LA encourages the use of this International guidance document for Certification Bodies which need to define their own surveillance activities.

Our organization is considering operating a scheme where the scheme owner notifies the clients of changes to the certification requirements themselves, and does not require any re-verification of compliance until the current certification expires. Does cl

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Clause 7.10.1 is required to be implemented by all certification bodies, regardless of what changes and subsequent action (or inaction) is stated by the scheme.
In all cases of certification changes, it remains the responsibility of the accredited certification body to be aware of these changes, to gain assurance that the changes have been communicated to clients in some manner, and to take some action to verify that the changes have been implemented by its clients. If the scheme specifies any further actions, such as mandating immediate re-evaluation of any certified product, then the certification body has further tasks to undertake.
In the case of a scheme owner sending out email notifications, actions taken by the CB to assure themselves that the communication has taken place may be minimal (but caution should still be taken in the event that a client is not receiving those notifications). In other cases, such as the CB being the scheme owner, a notification blast (e.g., via email or letter) to all clients could be submitted as evidence of the steps the CB has taken to comply with this requirement.
With regard to actions taken to verify implementation, these will depend on the instructions included (or not included) by the scheme owner. This might include re-evaluation of certified products (as mentioned previously), a re-review of currently certified product documentation and evaluation results to verify that the product continues to comply with certification requirements, an audit of client facilities, or even a simple evaluation of products at the next scheduled certification renewal point without taking immediate action.
However, in the event that the scheme or scheme owner is silent on actions to be taken, the certification body is still required to take some action of their own choosing to verify implementation of the changes by the client. This could include (for example) an analysis of the changes to determine whether or not re-evaluation is necessary, with a record of this analysis being kept. If any action is necessary, as per clause 7.10.3, it shall be performed in accordance with the appropriate part of section 7 of the standard, with records kept of those activities as required by section 7.12.

The certification scheme operated by my organization requires that we re-evaluate products on a four month cycle. Does the language in this clause mean that we only have to keep records for 8 months total, in order to meet the “current and previous” cycle

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Clause 8.4.2 of the standard indicates that the Certification Body’s procedures for record retention must be consistent with any contractual and legal obligations. Those legal and contractual obligations would take precedence over the shorter retention cycle given in the example above.
Above and beyond any legal or scheme obligations for record retention, A2LA requires, as one of the Conditions and Criteria for Accreditation (A2LA R102 - Conditions for Accreditation, clause 4), that the accredited (or applicant) organization must keep copies of records for the entire time period between on-site assessments. Legal and scheme obligations may require longer retention periods, but under no circumstances may the Certification Body dispose of records in any shorter time period.

How should my organization demonstrate compliance to this clause if we receive an anonymous complaint?

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In many instances, it may not be possible for a certification body to give a formal notice of complaint resolution to the complainant; one such example is if a complaint is received anonymously. Other examples where it may not be possible to formally notify a complainant could include the complainant not leaving any contact information for receiving feedback, or the complainant changing contact information either voluntarily (i.e. relocation) or involuntarily, (i.e. being dismissed from an employment position).
Possible evidence which would show that the certification body has performed their due diligence when the complainant is unreachable could include records of attempted emails with read receipts, phone logs, voicemails, certified postal mailings, or generalized resolution notices to alternate persons that are known to be related to the original complainant.
These examples, are not intended to be all-inclusive, nor are they mandatory actions that must be undertaken by the Certification Body.
Ultimately, the Certification Body must show evidence that they have done reasonable due diligence in attempting to contact or locate the original complainant, and these examples may be useful when considering what actions to undertake to notify the complainant of the outcome. In all cases, these attempts to contact the complainant must be part of the records associated with complaint resolution as required by clause 7.13.1.

What does A2LA consider to be “External documents” that my organization must control under our document control procedures?

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For the purposes of A2LA accreditation, accredited Certification Bodies are required to own or have direct access to, and have under their document control system, current versions of the normative documents that are vital to maintaining their accreditation and to perform their certification activities.
These documents include (in addition to relevant regulations, standards and/or technical methods, etc.) ISO/IEC 17065:2012, general A2LA policy documents, and the specific A2LA program requirement documents relating directly to their field of accreditation. A2LA does not consider “terminology documents”, such as ISO/IEC 17000 and the VIM, to be normative documents that an organization must control within their system.
For example, a Telecommunications Certification Body (TCB) would be expected to possess (or have direct access to) and have under its document control system current versions of the following A2LA documents:

Furthermore, such a TCB would be expected to control copies of all test methods called out in the certification schemes being operated, as well as copies of the schemes themselves.

I am a Certification Body getting ready to apply for accreditation to ISO/IEC 17065, do I have to perform a complete Management Review before I can become accredited?

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In order to confirm full compliance with this section of the Standard, A2LA assessors will look for evidence during the on-site assessment that a complete management review has been conducted in accordance with their documented procedure and pre-determined schedule (8.5.1.1).
If only a partial review has been conducted by the time of the on-site assessment, a deficiency will be cited and the full review must be completed before initial accreditation can be granted.

A2LA NOTE: This will be enforced for all applications received for both new certification bodies as well as certification bodies transitioning from ISO/IEC Guide 65 to ISO/IEC 17065

I am a Certification Body getting ready to apply for accreditation to ISO/IEC 17065, do I have to perform a complete Internal Audit before I can become accredited?

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In order to confirm full compliance with this section of the Standard, A2LA assessors will look for evidence during the on-site assessment that a complete internal audit has been conducted in accordance with their documented procedure (8.6.1) and pre-determined schedule (8.6.3).
If only a partial audit has been conducted by the time of the on-site assessment, a deficiency will be cited and the internal audit must be completed before initial accreditation is granted.

A2LA NOTE: This will be enforced for all applications received for both new certification bodies as well as certification bodies transitioning from ISO/IEC Guide 65 to ISO/IEC 17065

My internal audit process consists of only completing the A2LA C309 checklist – is this sufficient to demonstrate a complete internal audit?

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Not necessarily - The standard calls for the certification body to “verify that it fulfills the requirements of this International Standard, and that the management system is effectively implemented and maintained.” (emphasis added) A CB must provide evidence that their internal audit consists of at least the following:

Determination of compliance with all ISO/IEC 17065 requirements;

Determination of compliance with all policies, procedures, instructions, etc. that form your management system;

Determination of compliance with all relevant A2LA policies and requirements.

My Scope of Accreditation includes multiple product types under a larger scheme. Does my internal audit have to include every product type on my Scope?

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At a minimum, A2LA requires each scheme for which the certification body is accredited to be included in their Internal Audit in order to ensure that the steps in the certification process, as well as the CB's management system requirements are being properly implemented across all certification schemes offered.
The Internal Audit is considered incomplete if the organization fails to include all schemes during its internal audit. It is not required that every product type be addressed in one internal audit cycle, but it is recommended that different product types be reviewed from audit to audit.
As a reminder, Clause 8.6.2 requires the internal audit program to take into account previous audit findings - if any findings related to a specific product type were found at a previous audit, those must be taken into account when planning the current internal audit.

What does the standard mean when it says that my internal audit shall “normally” be performed at least once every 12 months?

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A certification body’s initial internal audit schedule should show that internal audits will be performed once in a 12 month period (or show that one full audit will be performed over a rolling 12 month period).f the certification body feels that they need to initially schedule more frequent audits, or if the results of any audit show the need to schedule a subsequent audit sooner than 12 months, the certification body should not hesitate to adjust their schedule accordingly.
Regardless of the period or frequency defined, any changes to the schedule of the audits as well as the rationale behind the decisions to change, must be documented and kept under record control by the certification body.
Any changes to reduce the frequency (that is, make the time span between internal audits longer) must be supported by records that demonstrate ongoing stability and effectiveness of the management system.

Is my organization required to keep records of training for our internal auditors?

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Clause 8.6.4(a) requires internal auditors to be competent in three areas – knowledge of the standard, knowledge of the certification process, and knowledge of auditing. The determination of auditor competence levels (that is, what an auditor needs to do to show they are “knowledgeable”) is the responsibility of the certification body, and records are required by A2LA to show that the auditors have demonstrated their knowledge to the certification body for whichever of the three aspects they are responsible for covering during an audit.

What does the standard mean when it states that my organization must ensure that any actions resulting from our internal audits are taken in a timely and appropriate manner?

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A2LA cannot define what “timely and appropriate” means for its certification bodies. The intent of this clause is for the organization to take action as soon as they are able, in order to ensure that the organization’s quality system is running smoothly, and that the certifications being offered are not negatively impacted. An assessor may cite a deficiency if there is evidence that the quality system or offered certifications are being affected by lack of action on an internal audit finding. The certification body is still responsible for meeting all requirements related to corrective actions (section 8.7) and preventive actions (section 8.8) when acting upon their internal audit findings.

What is a “Legally Enforceable Agreement”, and will my assessor be responsible for determining its legality?

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For purposes of this clause, A2LA determines a “legally enforceable agreement” to be any signed or sign-able record between the certification body and its client/customer which meets the requirements of clause 4.1.2.2, and which (as stated in 4.1.2.1) takes into account the responsibilities of the two parties in that agreement. This record can be known by any name, but is typically referred to as a “Contract” for ease of reference.
A2LA assessors will not be determining, nor can they be held responsible for, the legality of the certification body / client agreements. Their purpose is solely to find facts as to whether or not an agreement is in place which accounts for the responsibilities of the two parties and the client compliance requirements listed in clause 4.1.2.2.

Does our Certification Agreement need to list who is responsible (our organization, or the client) for the evaluation of a product when the scheme allows or requires the product to be evaluated before an application for certification can be filed? Or is a

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Historically, verbal agreements are difficult, if not impossible, to legally enforce. As such, because the Certification Agreement must be legally enforceable and must address the responsibilities of each party, A2LA requires that the responsibilities of the client with regard to any evaluation of the product performed prior to filing the application for certification be clearly outlined in writing in the Certification Agreement. This is also encompassed by clause 4.1.2.2.c.1 which requires the client to “make all necessary arrangements for… the conduct of the evaluation and surveillance (if required)…”

Is our organization required to keep records of all of the risks to impartiality we have investigated, even those which were determined not to be actual risks?

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A2LA expects certification bodies to keep records of any risks that have been identified, as well as records of the actions taken to mitigate the risks identified. This information is required to be passed to the Mechanism for Safeguarding Impartiality (as required by clause 4.2.4), which is then required to take this into account and provide feedback to the CB during its management review (clause 8.5.2).
While not required, it is recommended as a positive support to the principles of certification to keep records of all areas where an investigation into risks took place, even when no risk is ultimately identified. These records may help to assure stakeholders that the CB’s operations are transparent and impartial, and may further help the certification body in future risk analysis exercises in the event situations with its personnel or organizational relationships change.

Who determines the adequacy of my organization’s liability coverage arrangements?

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The Certification Body is responsible for determining what “adequate” levels are with respect to having liability coverage arrangements. As exemplified in this clause, such arrangement can include (but are not limited to) insurance and cash reserves. A2LA assessors may raise questions about the adequacy of these arrangements and how the organization felt they arrived at an adequate level of coverage. Additionally, A2LA assessors may raise questions about coverage for certain aspects of certification activities which are normally excluded from insurance policies.

Are expedite fees or volume discounts on certification fees considered discriminatory or undue financial conditions?

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In order for expedite fees or volume discounts (or other financial considerations between certifier and client) to be considered non-discriminatory and justifiable, the availability of such fees and discounts should be made known to all potential clients, and a process for applying such fees must be clearly laid out so that all parties taking advantage of them are considered equally. (Clause 4.6(b) of ISO/IEC 17065 requires that descriptions of fees charged to clients be documented and made available to clients upon request.)
While not explicitly required by the standard nor A2LA, if a certification body wishes to offer special pricing structures, it may be good practice to consider specifying “categories” that a client would fall into for these special pricing structures (e.g. “Clients with 0 to 50 applications per year receive no discount; 50 to 100 receive a 5% discount; etc.” or “To include your application in our expedited workflow line, the fee is xxx dollars due upon application receipt”). These suggested clarifications may assist the certification body in supporting their position if any questions over discriminatory practices are raised.
The certifier must take care to ensure that no special treatments are given, for example, to one client over another if both clients are equivalent in all other senses (e.g. both have paid the same expedite fee, or both have been informed of the same pricing discount). The fees, and the application of them, must not be constructed or used in such a manner as to impede or inhibit access by an otherwise qualified applicant.
If a potential client were to issue a complaint about the prices charged by a certifier, A2LA expects the certifier to keep a record of those complaints received, and any subsequent actions, as required by section 7.13 of ISO/IEC 17065.

Does my organization’s “Publicly Available Information” need to explicitly address each of the procedures called out in this clause if one or more are not applicable to our certification activities?

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Yes, the Certification Body must address each required procedure under this clause, even if the certification activities being performed do not include those actions. For example, an organization operating a certification scheme which does not allow for extensions or reductions to the scope of certification must have documented some statement to the effect of, “We do not offer any extensions or reductions to our certifications.”

My organization has invited numerous possible stakeholders to be part of our “Mechanism for Safeguarding Impartiality,” but all of those stakeholders have declined to participate. How can my organization show that we are maintaining the required balanced

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Note 2 to clause 5.2.1 and Note 1 to clause 5.2.4 of ISO/IEC 17065 both identify examples of mechanisms and potential invitees that the Certification Body may have overlooked during its invitation process, and should be examined prior to determining that all possible avenues have been exhausted.
The certification body must be able to demonstrate (e.g. by providing records) that they have ensured a balanced interest in their mechanism by identifying and inviting potentially interested parties, and that they have ensured that the composition of their Mechanism is such that no single interest predominates. In all cases, the certification body cannot hold more than 50% stake in this Mechanism – it is up to the certification body to take additional suitable actions to ensure that these balanced interest requirements are met.

What are the “applicable requirements” that Internal Resources must meet in order for my organization to comply with this clause?

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The “applicable requirements” that an internal resource must meet shall be defined and documented, and are considered to fall under the following hierarchy:

Requirements should be defined by the Certification Scheme;

If the requirements are not defined in the scheme, the Certification Body should define what requirements are or are NOT applicable in their quality system, with justification on any omitted clauses of the relevant International Standard(s);

If the CB and/or Scheme do not define the “applicable requirements,” an A2LA assessor will assume that all requirements in the relevant International Standard(s) are applicable.

A2LA NOTE – if an Evaluation standard (testing / inspection method specified in the Certification Scheme) explicitly requires an aspect contained in (for example) ISO/IEC 17020, 17021, or 17025, such as measurement uncertainty calculations, it cannot be excluded when considering whether or not the resource meets the requirements of those standards.

What are the “applicable requirements” that External Resources must meet in order for my organization to comply with this clause?

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The “applicable requirements” that an external resource must meet shall be defined and documented, and are considered to fall under the following hierarchy:

Requirements should be defined by the Certification Scheme;

If the requirements are not defined in the scheme, the Certification Body should define what requirements are or are NOT applicable in their quality system, with justification on any omitted clauses of the relevant International Standard(s);

If the CB and/or Scheme do not define the “applicable requirements,” an A2LA assessor will assume that all requirements in the relevant International Standard(s) are applicable.

A2LA NOTE – if an Evaluation standard (testing / inspection method specified in the Certification Scheme) explicitly requires an aspect contained in (for example) ISO/IEC 17020, 17021, or 17025, such as measurement uncertainty calculations, it cannot be excluded when considering whether or not the resource meets the requirements of those standards.

Explanations for the ISO/IEC 17020 Requirements

Who determines the adequacy of my organization's liability coverage arrangements?

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In some cases there may be contractual obligations which detail the minimum amount of coverage or there may be requirements imposed by the regulators for which the inspections are being performed or by the inspection scheme owners.
In the absence of such requirements, the inspection body is responsible for determining what “adequate” levels are with respect to having liability coverage arrangements. As exemplified in this clause, such arrangements can include insurance or cash reserves. A2LA assessors may raise questions about the adequacy of the coverage and how the organization arrived at the decision this was adequate coverage. Additionally, A2LA assessors may raise questions about coverage for certain aspects of the inspection activities which are normally excluded from insurance policies and write a deficiency if the policy will not cover accredited activities; an example of this would be a policy that did not cover data breaches for an organization that provide cyber security assessments.

Who is considered to be “top management”?

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For all types of inspection bodies, top management is considered to be those individuals who have the authority and can provide the resources necessary to make changes to any aspect regarding the inspection activities. Although it is up to the organization to identify top management, it is important that these individuals lead the management review and that it be clear in the records.

What constitutes “evidence of commitment” by top management?

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For either independent or in-house inspection bodies of larger organizations, top management is considered to be those individuals who have authority and can provide the resources necessary to make changes to any aspect within the inspection body. It is, therefore, important that these individuals participate in the management review, stress the importance of meeting customer requirements and ensure integrity of the management system. Evidence that proper resources are allocated to the performance of appropriate and effective internal audits, management reviews, etc. could also be considered evidence of top management’s commitment to its management system. As a result, records demonstrating top management’s participation in these functions could be considered evidence of compliance with this particular section of the standard.

What does A2LA consider to be external documents that my organization must control under our document control procedure?

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For the purposes of A2LA accreditation, accredited Inspection Bodies are required to own or have direct access to, and have under their document control system, current versions of the normative documents that are vital to maintaining their accreditation and to perform their inspection activities.
These documents include all relevant regulations, standards and/or technical methods, etc. related to the inspection activities. Additionally, ISO/IEC 17020:2012, general A2LA policy documents, and the specific A2LA program requirement documents relating directly to their field of accreditation. A2LA does not consider “terminology documents”, such as ISO/IEC 17000 and the VIM, to be normative documents that an organization must control within their system.
For inspection bodies the A2LA normative documents are as follows:
R301 – General Requirements: Accreditation of ISO/IEC 17020 Inspection Bodies
R102 – Conditions for Accreditation
R105 – Requirements When Making Reference to A2LA Accredited Status
P102 – A2LA Policy on Metrological Traceability (only when inspections require the use of traceable measuring equipment) or
P113 – A2LA Policy on Measurement Traceability for Life Sciences Testing and Forensic Conformity Assessment Bodies (CABs)(for Forensic organizations)
ILAC P15-Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies (This document can be found at ILAC.org)
Specific program requirements (examples):
R310 – Specific Requirements: Special Inspection Agencies Inspection Body Accreditation Program (only for special inspection agencies)
R311 – Specific Requirements: Federal Risk and Authorization Management Program (only for FedRAMP)
R318 – Specific Requirements: Forensic Examination Accreditation Program (only for forensic inspection)
R332 – Specific Requirements: NFPA Field Evaluation Bodies (only for NFPA field evaluation bodies)

What is the minimum amount of time I must retain records?

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In some instances external requirements, standards and specifications provide specific requirements for the retention of records. If there are no specifics provided then per A2LA requirement document R102-Conditions for Accreditation, item 4 states, “Retain all quality records and technical records supporting reported results throughout the period between A2LA full assessments bearing in mind that adequate records must be available to demonstrate full compliance with the requirements for accreditation.” Therefore, at minimum records shall be retained for the period of time from one full assessment to the next.

Can the results of an external audit be accepted as part of or entirely in place of an inspection body’s internal audit?

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No. ISO/IEC section 8.6.3 requires that the inspection body conduct internal audits. With the understanding that it is the inspection body’s responsibility to conduct their own internal audit, third party audits of the organization are not acceptable for meeting any portion of this requirement of the standard. Only internal audits completed by the inspection body staff or contracted consultants of the organization are acceptable.

My internal audit process consists of only completing the A2LA C301 checklist-is this sufficient to demonstrate a complete internal audit?

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Not necessarily - The standard calls for the inspection body to “verify that it fulfills the requirements of this International Standard, and that the management system is effectively implemented and maintained.” An inspection body must provide evidence that their internal audit consists of at least the following:
- Determination of compliance with all ISO/IEC 17020 requirements;
- Determination of compliance with all policies, procedures, inspection processes, instructions, etc. that form your management system;
- Determination of compliance with all relevant A2LA policies and requirements.
This can be done on the C301 checklist by confirming compliance and providing detailed notes on the objective evidence reviewed in making that determination. Where such detailed information on the C301 is not provided, the inspection body must maintain additional evidence that all requirements noted above were audited.

What is meant by “determining the causes of nonconformity” and how do I go about this?

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Determining the cause of nonconformity is deemed equivalent to root cause analysis. Root cause analysis can be the most challenging part of the corrective action process and should be used as a tool for continuous improvement, which may reduce or eliminate the likelihood of future deficiencies. Understanding why an event occurred is the key to developing effective corrective actions. In some cases, the root cause is singular and easily discerned; in most cases it is not, and there may be multiple root causes. Because of this, there is no single ‘recipe’ that can be followed. While it is impossible to create a procedure that would apply to all scenarios, there are some guiding principles which can be employed, the most important of which is that the root cause should address the question: “Why did this deficiency occur?”.
Other points to consider:

Statements of root cause which are essentially a restatement of the nonconformity provide no new information beyond the facts of what was found and are not considered to be an acceptable response.

Each non-conformance should be evaluated independently.

While each non-conformance and its associated root cause should be approached individually, trends in the identified root causes for a group of non-conformances is a strong indicator that further investigation is needed. For example, upon conclusion of an assessment during which 8 non-conformances were cited, it is determined that the root cause of 6 of the 8 non-conformances pertain to employee training. In this example, additional investigation into the employee training program would be prudent and should be evident in a response.

Additional resources that may be of help are found at:
"Presentation on Root Cause Analysis", found under "A2LA Guidance Documents" in the Document Finder on the A2LA website.
The February 2007 Issue of the A2LA Newsletter, found under the "Publications" tab, and "Newsletter Archive" menu item on the A2LA website.